- Finding the Right Balance | Giving to Johns Hopkins
- Gifts “keep this work going as quickly as possible”
- Vestibular Migraine
- What causes vestibular migraine?
- Vestibular Migraine Diagnosis
- Vestibular Migraine Treatment
- Vestibular Balance Disorder
- What causes vestibular balance disorders?
- What are the symptoms of vestibular balance disorders?
- How is vestibular balance disorder diagnosed?
- How is vestibular balance disorder treated?
- What are the complications of vestibular balance disorder?
- Living with vestibular balance disorder
- When should I call my healthcare provider?
- Key points about vestibular balance disorders
- Next steps
- Johns Hopkins Gazette | September 10, 2007
- What is Balance & Vertigo? | Audiology Services in Central Pennsylvania
- CHAMPIONS OF VESTIBULAR MEDICINE
- About Vestibular Disorders
- David Zee, MD – Johns Hopkins University
- Richard Clendaniel, PhD – Duke University
- Jeffrey Staab, MD, MS – Mayo Clinic
- Labyrinth Devices Multichannel Vestibular Implant Trial – Johns Hopkins Vestibular NeuroEngineering
- Vestibular Therapy | Johns Hopkins Physical Medicine and Rehabilitation
- Vestibular Rehabilitation: Why Choose Johns Hopkins
- Grand Rapids man one of the first to receive ‘bionic ear’
Finding the Right Balance | Giving to Johns Hopkins
Della Santina’s device uses a motion sensor in place of the cochlear implant’s microphone and attaches a stimulator to the vestibular nerve branches in the inner ear’s labyrinth instead of the cochlea. The stimulator tells the brain how fast the sensor is moving in every direction.
“The FDA originally required that we only let each subject use the device for two months, but all three of our participants wanted to keep using it,” Della Santina says of the early results from the vestibular implant’s clinical trials.
“When implanted patients move their heads, they now have a signal from their ear telling the brain ‘You’re moving your head: keep your eyes on target and turn on the reflexes you need to keep from falling down,'” Della Santina explains.
After more than a decade of development, Della Santina’s Vestibular NeuroEngineering Laboratory (VNEL) at Hopkins and start-up company, Labyrinth Devices, secured approval for a first-in-human trial of a Multichannel Vestibular Implant (MVI) VNEL technology in 2016. Three subjects have been implanted with the device, and Della Santina shared some early results from the trial at a July 2017 American Cochlear Implant Alliance Conference in San Francisco. One particular anecdote from the trial, he says, stands out.
“The FDA originally required that we only let each subject use the device for two months, but all three of our participants wanted to keep using it,” Della Santina says. The team solicited the FDA’s approval for extended use, and after the third subject joined the request, the agency granted it for all future subjects.
Gifts “keep this work going as quickly as possible”
Although National Institutes of Health (NIH) and industry funding played the most significant role in supporting the MVI’s development, philanthropy — including Sorenson’s support — has been indispensable.
It’s given Della Santina flexibility to bring on students and postdoctoral researchers whose work accelerates science crucial to guiding design of the next stage of a trial.
It’s also key to keeping a core team of researchers together for the time necessary to bring a medical innovation to market, particularly in between grant cycles.
“We’re in the final year of our grant support for the clinical trial, so in the next six months, I’ll need to find support to keep our clinical research, basic science and engineering teams together,” Della Santina says, noting that several of his staff have caught the eye of competitor institutions. “An endowed lab would give us strong foundation to keep this work going as quickly as possible.”
Donors Sorensen are also important because they serve as evangelists for work Hopkins researchers are pursuing. And that’s a role Sorensen’s proud to play on Della Santina’s behalf.
“There are so many people who have these dreadful, debilitating conditions who could possibly be helped by Dr. Della Santina’s work,” Sorensen says. “I’m fortunate to be in a position to support him.”
Migraine headaches are a common neurological condition. Although common migraines are characterized by a moderate to severe pounding or throbbing headache, vestibular migraine may or may not involve headaches in combination with vestibular symptoms such as vertigo, imbalance, nausea and vomiting.
What You Need to Know
- Vestibular migraine can cause vestibular or balance symptoms with or without an actual headache.
- There is almost always a history of motion sensitivity (such as car sickness) since childhood, and migraine headaches at some point in the person's lifetime, even if they last occurred decades ago.
- Vestibular migraine isn’t fully understood but seems to result from overlapping pathways that modulate pain and vestibular inputs into the brain.
- Many of the triggers for migraine headaches can cause a vestibular migraine.
- Vestibular migraines can involve combinations of the following symptoms:
- Migraine headache symptoms, such as
- Severe, throbbing headache, usually on one side of the head
- Nausea and vomiting
- Sensitivity to light, smell and noise
- Vestibular symptoms may include:
- Vertigo (dizziness), usually lasting minutes to hours, but sometimes days
- Unsteadiness and loss of balance
- Sensitivity to motion
Although subjective hearing symptoms (ringing, fullness, pressure in one or both ears) are common, significant hearing loss should raise suspicion for an inner ear disorder such as Méniére’s disease.
With a vestibular migraine, the person may experience a combination of vestibular attacks, visual aura, or sensitivity to visual stimulation and motion at different times, and they can occur with or without an actual headache.
What causes vestibular migraine?
Vestibular migraines, other migraine syndromes, tend to run in families. Although science has not completely clarified the complex mechanisms of migraine, it is known that women tend to suffer more from the condition than men, and symptoms may get worse around menstruation.
In addition, people vulnerable to vestibular migraines can experience episodes after migraine triggers including altered sleep patterns, MSG, menstrual cycle and food such as chocolate, ripened or aged cheese and red wine.
Vestibular Migraine Diagnosis
Because a majority of people who have vestibular migraine do not have vestibular symptoms and headaches occurring at the same time, the onset of dizziness by itself may make it challenging to arrive at a diagnosis. Other diagnostic considerations that can present similarly to vestibular migraine include:
It is common for vestibular migraine, Méniére’s disease and BPPV to coexist, which can make diagnosis and treatment even more challenging.
Vestibular Migraine Treatment
Treatment for vestibular migraine is similar to that for other migraine headaches. Use of meclizine or other abortive medications that suppress the vestibular system should be minimized, and only used occasionally as needed, during an episode for instance.
If the person is getting frequent attacks, the doctor may recommend one or more of these medications, as well as others:
- Calcium channel blockers
- Tricyclic antidepressants
- Serotonin or serotonin/norepinephrine reuptake inhibitors (SSRIs or SNRIs)
People with vestibular migraines can reduce the number and intensity of episodes by maintaining a regular sleep and meal schedule, avoiding triggers, exercising regularly and managing stress.
Vestibular Balance Disorder
Linkedin Pinterest Ear Nose and Throat
Dizziness and vertigo are symptoms of a vestibular balance disorder. Balance disorders can strike at any age, but are most common as you get older.
Your ear is a complex system of bone and cartilage. Within it is a network of canals. These are called semicircular canals. The canals are filled with fluid. The position of the fluid changes with movement. A sensor in the ear then sends the information to your brain to contribute to your sense of balance. These and other delicate pieces make up the vestibular system.
Certain things can affect the signals from any of the parts of the vestibular system causing symptoms.
What causes vestibular balance disorders?
Common causes of vestibular balance disorders include:
- Inner ear problems, such as poor circulation in the ear
- Calcium debris in your semicircular canals
- Problems rooted in your brain, such as traumatic brain injury
What are the symptoms of vestibular balance disorders?
The symptoms of a vestibular balance disorder include:
- Feeling off-balance
- Feeling as if you are floating or as if the world is spinning
- Blurred vision
- Falling or stumbling
Less common symptoms include:
- Changes in your heart's rhythm
How is vestibular balance disorder diagnosed?
You may need to work with an ear, nose, and throat specialist (ENT, or otolaryngologist). Many conditions can cause dizziness and lightheadedness. Part of the diagnosis may involve ruling out other causes.
After reviewing your medical history, your healthcare provider may do the following:
- Hearing exam
- Vision exam
- Blood tests
- Imaging tests of the head and brain
- Clinical tests of balance
- Look at your posture and movement, using a structured, exam called a posturography
How is vestibular balance disorder treated?
Treatment will depend on the cause of your balance disorder and may include:
- Treating any underlying causes. Depending on the cause, you may need antibiotics or antifungal treatments. These can treat ear infections that are causing your balance disorder.
- Changes in lifestyle. You may be able to ease some symptoms with changes in diet and activity. This includes quitting smoking or avoiding nicotine.
- Epley maneuver (Canalith repositioning maneuvers). These are a specialized series of movements of your head and chest. The goal is to reposition particles in your semicircular canals into a position where they don’t trigger symptoms.
- Surgery. When medicine and other therapies are unable to control your symptoms, you may need surgery. The procedure depends on the underlying cause of the disorder. The goal is to stabilize and repair inner ear function.
- Rehabilitation. If you struggle with vestibular balance disorders, you may need vestibular rehabilitation or balance retraining therapy. This helps you move through your day safely. A rehabilitation specialist will help you learn how to cope with dizziness in your daily life. You may need to learn better safety strategies and make adjustments for
- Going up and down stairs
- Driving (ask your healthcare provider when it will be safe for you to drive)
- Walking and exercising
- Using the bathroom
- Organizing your home to make it safer, such as tightening handrails
- Changing your shoes or clothing, such as wearing low heeled shoe
- Changing your daily habits, such as planning your day so that you won't be walking in the dark
- Learning how to use a cane or walker
What are the complications of vestibular balance disorder?
Possible complications include:
- Injury from falling
- Reduced quality of life
Living with vestibular balance disorder
The symptoms of vestibular balance disorder can interfere with regular daily activities and your ability to drive, work, or enjoy recreation activities. This can cause symptoms of depression and frustration. Counseling can help you learn to cope with the disorder and life style impacts.
When should I call my healthcare provider?
Feeling lightheaded or dizzy occasionally happens to most people. If these sensations are frequent and affect your quality of life, contact your healthcare provider.
Key points about vestibular balance disorders
- Vestibular balance disorders can affect orientation and balance.
- Treatment depends on the underlying cause and can include medicine, rehabilitation, and lifestyle changes. You may need surgery for symptoms that do not resolve with other treatments.
- Talk to your healthcare provider if you have symptoms of vertigo, dizziness, or hearing changes. These can mean you have a vestibular balance disorder.
Tips to help you get the most from a visit to your healthcare provider:
- Know the reason for your visit and what you want to happen.
- Before your visit, write down questions you want answered.
- Bring someone with you to help you ask questions and remember what your provider tells you.
- At the visit, write down the name of a new diagnosis, and any new medicines, treatments, or tests. Also write down any new instructions your provider gives you.
- Know why a new medicine or treatment is prescribed, and how it will help you. Also know what the side effects are.
- Ask if your condition can be treated in other ways.
- Know why a test or procedure is recommended and what the results could mean.
- Know what to expect if you do not take the medicine or have the test or procedure.
- If you have a follow-up appointment, write down the date, time, and purpose for that visit.
- Know how you can contact your provider if you have questions.
Johns Hopkins Gazette | September 10, 2007
Hearingand balance experts at Johns Hopkins report successfultesting in animals of an electrical device that partly restores a damaged orimpaired sense of balance.
Though human testing of the so-called multichannelvestibular prosthesis remains a few years away, the scientists say that such a device, which ispartially implanted in the inner ear, could aid the 30,000 Americans the experts' estimates show are copingwith profound loss of inner ear balance.
These people often suffer from unsteadiness, disequilibriumor wobbly vision. Problems with vestibular sensation can be inherited at birth or result from use ofantibiotics, chemotherapy drugs, Meniere's disease, viral infection, stroke or head trauma.
The study, done in chinchillas because their inner earfunction is well studied, “is proof of concept that we can restore three-dimensional sensation ofhead movement with a multichannel vestibular prosthesis,” said Charles C. Della Santina,director of the Vestibular Neuroengineering Laboratory at Johns Hopkins.
“While everyone knows about the five senses of sight,smell, taste, touch and hearing, few people think about a possible sixth sense — thesensation of head orientation and movement — untilthe system fails,” said Della Santina, who has been working onthis prosthesis since 2002.
In its report in the June edition of the journalI.E.E.E. Transactions on Biomedical Engineering, the Johns Hopkins team showed that a matchbox-sizeprototype device, weighing less than three ounces, effectively mimics the workings of the inner ear'sthree semicircular canals by sensing head rotation and transmitting that information to the brain.
Adapting the design of cochlear implants, whichrestore hearing through electrical stimulation of the cochlear nerve, researchers constructed a circuitthat could measure and transmit 3-D balance information to the brain through multiple electrodesconnected to the vestibular nerve.
The device, which researchers started testing morethan a year ago, consists of a head-mounted battery-operated box containing the sensors, whichare positioned outside the head so that the sensors are parallel to the animal's actualsemicircular canals, where head rotation is normally sensed. The sensors are connected to a microprocessor andup to eight electrodes surgically implanted in the inner ear and separately connected to nerve endings.Each electrode can act as one information channel.
Della Santina says that people disabled by loss ofvestibular sensation often feel chronically off balance and lose the ability to keep the eyes steadilypointed at an object when they move their head, “seeing the world the wobbly image on a shaky handheldvideo camera.”
According to Della Santina, an assistant professor ofotolaryngology — head and neck surgery and biomedical engineering at the School of Medicine, thisis the first implantable device made with multiple sensors and channels of processing that canmeasure and encode head rotation in all directions.
Each of the three sensors, he notes, can measure thespeed of head rotation about one of three axes, or directional planes.
Della Santina says that previous implants developedelsewhere were limited to one functioning sensor and electrode and one plane or axis of rotation,”when, in reality, we move in multiple directions.”
Every measurement in the balance device is processedin the implanted central microprocessor unit, using computer software developed by Della Santinaand his team.
Once processed, the information is used to tailortiming of brief electronic pulses through the electrodes implanted near the three branches of thevestibular nerve that respond to changes in head rotation. These branches normally carry signals from theinner ear's three semicircular canals.
In the chinchilla tests, pulses lasting less than amillisecond were delivered with timing patterns that mimicked normal nerve activity.
Della Santina and his colleagues first causedimbalance in chinchillas by treating them with a high dose of gentamicin, an antibiotic known to wipe outthe tiny hair projections on cells in the inner ear canals that are normally key to sensory balancefunction.
Treated animals displayed unsteady walking and wobbly eye movements commonly seen in peoplewith impaired balance. Precise measurements of eye movements, using a technique of videotracking adapted by researchers, were made during a fixed set of head movements.
Resultsconfirmed profound loss of normal eye-stabilizing reflexes.
The animals were then fitted with the vestibularprosthesis, with sensors oriented parallel to the semicircular canals they replaced. Post-activation eyetesting in three chinchillas showed that the animals partially regained their vision-stabilizingreflex.
Researchers say that many hurdles remain before ahuman device will be available.
Efforts are under way to reduce electrical interference to other nervebranches and to refine the timing patterns of electrical stimulation to make them more normal.
Inaddition, the scientists plan to work on making the device smaller and hermetically sealed so thatit can fit completely inside the head beneath the skin.
The resulting vestibular implant, they say, couldultimately serve as a safety net, for example, for people who need high-dose gentamicin therapy to combatsevere abdominal infections after bowel surgery.
“People with profoundly impaired balance need bettertreatment options,” Della Santina said. “Many cope through rehabilitation exercises or byrestricting their activities, but the chronic disequilibrium and blurry vision can be disabling.”
The study was funded by the National Institute onDeafness and Other Communication Disorders, a member of the National Institutes of Health;and by the American Otological Society.
Patents are pending on several aspects of theprosthesis.
Other researchers involved in this study were AmericoMigliaccio and Amit Patel.
What is Balance & Vertigo? | Audiology Services in Central Pennsylvania
Vertigo usually results from a problem with the nerves and the structures of the balance mechanism in your inner ear (vestibular system), which sense movement and changes in your head position. Sitting up or moving around may make it worse. Sometimes vertigo is severe enough to cause nausea, vomiting and imbalance.
Causes of vertigo may include:
- Benign paroxysmal positional vertigo (BPPV).BPPV causes intense, brief episodes of vertigo immediately following a change in the position of your head, often when you turn over in bed or sit up in the morning. BPPV is the most common cause of vertigo.
- Inflammation in the inner ear.Signs and symptoms of inflammation of your inner ear (acute vestibular neuritis) include the spontaneous onset of intense, constant vertigo that may persist for several days, along with nausea, vomiting and imbalance. It can be incapacitating, requiring bed rest. When associated with sudden hearing loss, this condition is referred to as labyrinthitis. Fortunately, vestibular neuritis generally subsides and clears up on its own.
- Meniere’s disease.This disease involves the excessive buildup of fluid in your inner ear. It is an uncommon condition that may affect adults at any age and is characterized by sudden episodes of vertigo lasting 30 minutes to several hours and hearing loss.
- Migrainous vertigo.Migraine is more than a headache disorder. Just as some people experience a visual “aura” with their migraines, others can get vertigo episodes and have other types of dizziness between migraines.
- Acoustic neuroma.An acoustic neuroma (vestibular schwannoma) is a noncancerous (benign) growth on the vestibular nerve, which connects the inner ear to your brain. Symptoms of an acoustic neuroma generally include progressive hearing loss and tinnitus on one side accompanied by dizziness or imbalance.
- Superior canal dehiscence syndrome (SCDS)A rare medical condition of the inner ear, leading to hearing and balance symptoms in those affected. The symptoms are caused by a thinning or complete absence of the part of the temporal bone overlying the superior semicircular canal of the vestibular system. There is evidence that this rare defect, or susceptibility, is congenital. There are also numerous cases of symptoms arising after physical trauma to the head. It was first described in 1998 by Dr. Lloyd B. Minor of Johns Hopkins University, Baltimore, USA
- Other causes.Rarely, vertigo can be a symptom of a more serious neurological problem such as a stroke, brain hemorrhage or multiple sclerosis. In such cases, other neurological symptoms are usually present, such as double vision, slurred speech, facial weakness or numbness, limb coordination, or severe balance problems.
The type of symptoms, whether it is dizziness, vertigo or imbalance, often helps determine the type of problem you have. Many times we have to do multiple tests to narrow down the cause of the symptoms so that proper treatment can be prescribed. In many cases multiple professionals can be involved in the final diagnosis of vestibular symptoms.
CHAMPIONS OF VESTIBULAR MEDICINE
The Vestibular Disorders Association (VeDA) announces the annual VeDA Champion of Vestibular Medicine Award initiative to increase awareness of vestibular disorders that affect the inner ear and brain. 2017 award recipients include David Zee, MD, Richard Clendaniel, PhD, and Jeffrey Staab, MD, MS.
“Champions of Vestibular Medicine are medical professionals who have had significant impact on increasing awareness of vestibular disorders,” says Cynthia Ryan, VeDA’s executive director. “Thanks to their leadership we’re seeing new diagnostic tools and treatment protocols that help reduce diagnosis times and increase treatment effectiveness.”“So many vestibular patients suffer for years before receiving an accurate diagnosis, if they ever get one,” says Louise Geib, President of VeDA’s board of directors. “VeDA’s number one goal is to reduce the time it takes to diagnose a vestibular disorder. We want to shine a light on this invisible illness so that vestibular patients don’t feel so alone.”
About Vestibular Disorders
The vestibular system includes the parts of the inner ear and brain that process the sensory information involved with controlling balance and eye movements. If disease or injury damages these processing areas, vestibular disorders can result. Vestibular disorders can also result from or be worsened by genetic or environmental conditions. Many occur for unknown reasons.
One large epidemiological study estimates that as many as 35 of adults aged 40 years or older in the United States—approximately 69 million Americans—have experienced some form of vestibular dysfunction.
David Zee, MD – Johns Hopkins University
Dr. Zee is a clinician who has diagnosed and treated vestibular patients for nearly five decades, a scientist who has done groundbreaking research in how the brain reacts, compensates and recovers from vestibular disorders, and a teacher who has mentored and educated clinicians and scientists around the world.
He is an internationally-recognized leader whose name is virtually synonymous with the study and bedside evaluation of eye movements. He has more than 450 publications, and was coauthor of the definitive textbook on eye movement disorders in neurological disease.
Recently he discovered how magnetic fields of MRI machines stimulate the inner ear and cause vertigo and nystagmus. His scholarship and teaching have exerted a major influence in neurology, neuroscience, ophthalmology and otolaryngology.
He has taught “Masters” courses all over the world, and recently received a National Health Information Award for educational videotapes for patients on dizziness.
Richard Clendaniel, PhD – Duke University
Dr. Clendaniel is a scientist, educator, clinician, and mentor for Duke University’s physical therapy doctoral program. His training and scientific practice have made him a recognized expert in the rehabilitation of individuals with vestibular disorders.
He is one of the founding directors of Emory University’s Vestibular Rehabilitation: A Competency Based Course (formerly known as the Herdman Vestibular Course), which is recognized as the gold standard in professional education for the evaluation and treatment of vestibular disorders. He has contributed significant observations and insights to the scholarly literature of vestibular medicine, notably, the development of guidelines for vestibular rehabilitation, and multiple important investigations into the role and behavior of the visual system in vestibular dysfunction.
Jeffrey Staab, MD, MS – Mayo Clinic
Dr. Staab's research is in the area of psychosomatic and behavioral medicine. He was the lead investigator and principal proponent in a series of clinical studies examining factors associated with unexplained chronic dizziness. Dr.
Staab's work in dizziness has helped to define interactions between neurotologic and behavioral variables that trigger and sustain persistent dizziness.
He and his colleagues described a syndrome recently termed Persistent Postural-Perceptual Dizziness, or PPPD, which afflicts many patients in the aftermath of acute vertigo or imbalance.
His work has shown that this is an identifiable syndrome that is NOT a psychiatric disorder, and that it is highly associated with anxiety, vestibular migraines, and other disorders of the vestibular system. Dr. Staab led the first studies of medications to treat PPPD, and is currently looking for a biomarker for this disorder.
Labyrinth Devices Multichannel Vestibular Implant Trial – Johns Hopkins Vestibular NeuroEngineering
What is this study about?
Thisresearch is being done to evaluate the safety and ability of a new implanteddevice to help people who have lost most or all vestibular sensation (inner earbalance function). The vestibular part of the inner ear senses head tilt androtation during movements walking.
This information drives reflexes thathelp maintain balance and help keep your eyes and vision stable while you aremoving. People who have lost most vestibular sensation in both ears oftensuffer imbalance, dizziness, difficulty walking in darkness without falling,and blurred or unsteady vision during head movement.
Gentamicin toxicity is oneof the most common causes of this problem, but there are other causes, as well.
In this study, we are studying eye and head movements in people who have lostinner ear balance function, before and after surgical implantation, activationand deactivation of a new electronic implant designed to measure head movementand to stimulate the vestibular nerve in the inner ear. This device, the MultichannelVestibular Implant, is a cochlear implant except that it is designed to sensemotion rather than sound and to stimulate a different part of the inner ear.
Use of the Multichannel Vestibular Implant in this research study is investigational. The word “investigational” means that the Multichannel Vestibular Implant is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of the Multichannel Vestibular Implant in this study under an investigational device exemption.
This approach differs from standard clinical care for bilateral loss of vestibular sensation in that it involves surgical implantation of an electronic stimulator. This is the first time the Multichannel Vestibular Implant is being used in humans. Versions of it have previously been tested in animals.
In this study, we will use the implant in only one ear (the study ear).
Am I eligible?
Participants must be 22 to 90 years old with severe loss of inner ear balance sensation in both ears and good hearing in at least one ear.
You will be unable to participate if your vestibular dysfunction is known to be caused by reasons other than inner ear injury due to ototoxicity, loss of blood flow to the inner ear, trauma, infection, Meniere’s disease, or genetic defects known to act on inner ear hair cells. Also, participants will be excluded if they have cochlear implants, on-going vertigo due to active Meniere's disease, immunodeficiency diseases or other medical conditions expected to prevent safe completion of all study procedures
What is involved?
Participation lasts approximately 14 months, including about 2 months to perform initial tests and schedule surgery. The initial tests are part of the screening period, when participants are thoroughly evaluated for auditory (hearing) and vestibular (balance) function. Those who qualify will receive an operation to have the vestibular implant inserted under the skin behind the ear and into the inner ear in a surgery similar to cochlear implantation. During the first 4 months after surgery, the device will be activated and then deactivated. You will then be evaluated in follow-up appointments every quarter (3 months) until 1 year after implant surgery.
How can I learn more about this study?
1. Contact Study Coordinator Kelly Lane at firstname.lastname@example.org
2. Go to the study's listing on ClinicalTrials.gov here.
What information will I need if I want to apply to participate in the trial?
A list of the questions and information that will be required to determine whether you may be a candidate for this study is here.
How can I apply to participate in the trial?
You can apply to participate in the study by clicking here. That link connects you to a survey where you can answer questions that will help determine if you are a candidate for the study. You'll be asked to supply records for vestibular, hearing and imaging test reports.
Applying to join the study is easiest if you already have those documents saved as digital files ( PDF files produced by a scanner), because you can then upload them directly to our secure server at that site.
The application website will also give you the option of uploading the files later, or mailing hard copies, or faxing.
Where will the study be done?
This study will be performed at the Johns Hopkins Outpatient Center and Johns Hopkins Hospital in Baltimore, Maryland. Although we anticipate that future phases of clinical study will include other sites in the United Sates and abroad, this first trial will be limited to a single site.
Who manufactures the vestibular implant used in this study?
This study will use the MVITM Multichannel Vestibular Implant System developed and manufactured by Labyrinth Devices, LLC in collaboration with MedEl GmbH (which makes the implanted stimulator part of the system). The MVITM system is technology developed in the Johns Hopkins Vestibular NeuroEngineering Lab and licensed by Labyrinth Devices from the Johns Hopkins University.
Who are the investigators?
This study will be performed by members of the Johns Hopkins Vestibular NeuroEngineering Laboratory, which is led by Charles C. Della Santina MD PhD. As the founder and CEO of Labyrinth Devices, LLC, Dr.
Della Santina holds an equity interest in the company, creating a conflict of interest that is managed by the Johns Hopkins Office of Policy Coordination in accordance with Johns Hopkins University policy. John P.
Carey MD, who has no affiliation with Labyrinth Devices, is the non-conflicted principal investigator for the study, which has been approved by the Johns Hopkins School of Medicine Institutional Review Board (protocol NA_00051349).
Has the vestibular implant used in this study been approved by the FDA?
The FDA has approved an investigational device exemption (IDE) permitting use of the Labyrinth Devices MVITM Multichannel Vestibular Implant System in this study.
An IDE approval to perform a study is not the same as the premarket approval required before a medical device can be adopted into routine clinical use outside of a strictly supervised clinical trial, so use of the system is currently limited to participants in this study.
The FDA has also granted Humanitarian Use Designation (HUD) to the Labyrinth Devices MVITM Multichannel Vestibular Implant System.
Find this site again quickly by searching: “Johns Hopkins Vestibular Implant Trial”
Vestibular Therapy | Johns Hopkins Physical Medicine and Rehabilitation
Feeling dizzy, unsteady or disoriented is not just unpleasant — it can put you at risk for falls and serious injuries. Our vestibular rehabilitation program aims to help children and adults reduce dizziness resulting from a variety of inner ear disorders and neurologic conditions, including benign paroxysmal positional vertigo (BPPV), post-concussion syndrome and vestibular migraines.
Vestibular Rehabilitation: Why Choose Johns Hopkins
- Our team of physical therapists includes several certified vestibular and neurologic specialists, as well as therapists experienced in vestibular exercises and BPPV repositioning maneuvers.
- We can help you address dizziness and related issues, such as nausea, lightheadedness, imbalance, oscillopsia (visual blurring) and motion sensitivity.
- We have access to the latest diagnostic and exercise technology for vestibular rehabilitation, including infrared goggles (at our downtown location) that record eye movement to evaluate balance centers.
- Our therapy programs are customized for each patient your unique challenges, lifestyle, health issues and exercise tolerance.
- Vestibular hypofunction (balance disorder of the inner ear)
- Labyrinthitis (inflammation of the inner ear)
- Vestibular neuritis (inflammation of the auditory nerve’s vestibular portion)
- Bilateral vestibulopathy (damage of both inner ears)
- Vestibular schwannoma (acoustic neuroma)
- BPPV (It occurs when tiny calcium crystals come loose from their normal location in the inner ear.)
- Meniere’s disease
- Concussion and post-concussion syndrome
- Traumatic brain injury
- Vestibular migraine
- Functional movement disorder
- Persistent postural-perceptual dizziness (PPPD)
- Cerebellar disorders (ataxia)
- Progressive supranuclear palsy (PSP)
- Multiple sclerosis
The goals of vestibular therapy may differ depending on the underlying conditions causing your dizziness. Vestibular rehabilitation may help you:
- Reduce dizziness and related symptoms
- Regain function
- Reposition inner ear debris (calcium crystals) in cases of BPPV
- Develop compensatory mechanisms in the brain through other senses such as vision
Therapy ranges from repositioning maneuvers for BPPV, to balance and vestibular exercises to improve stability in various environments and on different surfaces.
Schedule an appointment with one of our vestibular therapists to find a treatment that can help relieve your vestibular symptoms.
You can find our vestibular therapists at several convenient locations in the Baltimore area:
- The Johns Hopkins Hospital
- Green Spring Station Clinic
- White Marsh Clinic
- Odenton Clinic
- Johns Hopkins Children’s Center
Get addresses and directions. | Meet our team.
Grand Rapids man one of the first to receive ‘bionic ear’
GRAND RAPIDS, MI — A Grand Rapids man is the eighth in the world to receive an experimental implant that some are calling a “bionic ear.”
The vestibular implant is a device similar to the cochlear implant, which is used for people who have hearing loss. But it serves a different purpose — to restore balance when people have the lost the function of their inner ears.
The vestibular implant has three electrodes that connect to the semicircular canals, the fluid-filled tubes in the ear that maintain balance.
The electrodes send signals from an external gyroscope, a magnetic attachment placed on the outside of the head, to the ear, where those signals will be interpreted as head motion.
The ear then sends signals to the eyes and muscles to anticipate and coordinate movement.
Physicians, researchers and medical engineers from all over the world are working at Johns Hopkins Hospital in Baltimore to develop this experimental technology. Their next trial patient is 55-year old Shawn Macauley.
For the last 23 years, Macauley has been struggling with his balance.
After having some dental work back in 1996, he got an infection. A doctor prescribed too much of the antibiotic gentamicin and as a side effect, Macauley’s inner ears were “destroyed,” and with that, his balance, he said.
“For the next nine years, I was on total disability,” Macauley said. “I had to learn how to walk again and drive again and, basically, live again.”
What most people don’t know, Macauley said, is that your ear has a lot to do with your balance.
According to Johns Hopkins Medicine, the vestibular part of the ear senses head tilt and rotation when moving. Without the vestibules in the ear telling the eyes, brain and limbs how to react, people who have lost vestibular sensation suffer from imbalance, dizziness and blurred or unsteady vision with head movement.
Years of therapy helped Macauley, who now uses a walker, get used to the feelings of dizziness and nausea so that he can function somewhat normally. He is back to work as a professor of anatomy at Muskegon Community College, and he can get around walking and driving.
“When I walk now, I can’t see,” Macauley said. “Everything blurs, everything moves, I’m always sort of in this dizzy state.”
While Macauley can mask it well at this point, he’s had people think he’s intoxicated when he stumbles in public. People have approached him at movie theaters, parks and he has even been denied getting on an airplane because people accused him of being drunk.
“People, rather than trying to be empathetic, are talking behind my back or steering away from me,” Macauley said. “You get tired of the looks. You get tired of people whispering.”
Macauley just recently got the internal magnetic pieces of the experimental implant surgically put into his head, and effectively lost his hearing in his right ear, the side where everything originated. He said loss of hearing in his ear is a definite risk to getting the implant, but he’s willing to take that chance to regain his sense of balance.
“I want to get better myself,” Macauley said. “If I can help the technology get better, if I can help move this field further, then that’s worth it.”
Over 300 people applied to participate in the trial, although some of those may be repeat applications. The U.S. Food and Drug Administration, FDA, approved this trial through a strictly regulated Investigational Device Exemption.
Macauley faces a unique risk that his balance won’t be restored because he’s had vestibular dysfunction for 23 years. The longest any of the other patients with the device had gone with the dysfunction was 12 years, so there is a chance Macauley’s body will have a harder time adapting, he said.
Taking the lead in the work is Dr. Charley Della Santina, who runs the Johns Hopkins Vestibular NeuroEngineering Lab that is overseeing the study. He also is the principal investigator on the grant that is funding the study and is the CEO of Labyrinth Devices, one of the companies creating the implant device.
“Other than doing rehabilitation exercises, we really don’t have anything to offer patients who’ve lost inner ear balance function,” Della Santina said.
Della Santina added that about 60,000 to 100,000 people in the U.S. and about one million people in the word suffer loss of vestibular function.
A professor of anatomy himself, Macauley uses himself as an example to his students who are medical and nursing majors.
“As a healthcare professional, if something doesn’t seem right, you say something, and you keep saying it,” Macauley said. “The second lesson is before you take a drug be fully aware of the possible complications and ask questions.”
This coming week, Macauley will travel back to Maryland to get the outer part of the implant installed in his head. He’s hoping his hearing will come back, but there’s no guarantee, as the device is still being developed.
All medical, travel and lodging expenses have been covered by Johns Hopkins, Macauley said. Otherwise, his insurance would not have covered it because it’s experimental work.
Della Santina said he hopes the development of the vestibular implant can be similar to the cochlear implant, which has been used for decades by modern medicine.
“Our immediate goal is to try to get the best possible outcome for subjects in this trial, while at the same time using this experience to learn what works best, what doesn’t work well,” Della Santina said. “How to optimize the hardware, the surgery, the stimulus parameters, our approach to programming devices, so we can get our patients the best possible outcome.”