An interventional study of Placebo device and PoNS™ device in Hearing and Vestibular Disorders, sponsored by United States Naval Medical Center, San Diego. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by United States Naval Medical Center, San Diego · Not applicable, Interventional, and Treatment
Among 54 studies in Vestibular Diseases with a site in United States — 14 open to participants now, 16 under way, none of them phase 3. Vestibular Diseases · United States.
Among the 54 studies in Vestibular Diseases with a site in United States, this one is the 42nd largest by enrollment of the 48 interventional ones that give a count, is one of 2 that started in 2013, is one of 44 with no phase, and was the 8th registered.
170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
Browse Vestibular Diseases studies →14 of the 54 studies in Vestibular Diseases with a site in United States are open now. Recruiting first, the newest first:
Massachusetts Eye and Ear Infirmary · Sites in United States
Ages 21+ · Healthy volunteers
Creighton University · Sites in United States
Ages 19–89 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 22–90
Association of Migraine Disorders · Sites in United States
Ages 18+ · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 65–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 21 Vestibular Diseases studies recruiting now, 6 (29%) set no upper age limit and 9 (43%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 40 Years · all sexes · no healthy volunteers.
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54 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2013.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 32 across the 48 interventional studies, 143 across the 6 observational. Of the 28 that completed or were terminated, 9 (32%) have results posted.
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10 of 54 have an industry lead sponsor. The 10 most frequent:
United States Naval Medical Center, San Diego is the lead sponsor of 65 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
United States Naval Medical Center, San Diego has 1 study filed under Vestibular Diseases — fewer than ten, so there is no comparison to draw.
7 of the studies in Vestibular Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05674786Johns Hopkins UniversityVestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction | 2026-12-31 |
| NCT06732440Creighton UniversitySubthreshold Vestibular Stimulation as a Strategy for Rehabilitation | 2026-12-31 |
| NCT07081542AdventHealthComparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants | 2027-01-31 |
| NCT05622344Johns Hopkins UniversityStableEyes With Active Neurofeedback | 2027-03-30 |
| NCT06688578Massachusetts Eye and Ear InfirmaryTesting Effectiveness of a Stochastic Noise Stimulator to Immediately Improve Balance and Gait | 2027-05-31 |
Add all 7 to your calendar (.ics) → With an account.
Among the 54 studies in Vestibular Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Traumatic brain injury (TBI) is a major worldwide health issue. Figures from the Centers for Disease control show that 1.7 million people suffer a TBI annually. Meanwhile the World Health Organization recognizes TBI as one of the most significant health issues in developing countries. In the military, mild traumatic brain injury (mTBI) is one of the most frequent sequela of modern war. Dizziness and balance disorders are the most frequent sequela of mTBI and account for a significant degree of mTBI morbidity. At the current time, the best treatment modality for dizziness secondary to mTBI is vestibular rehabilitation (VR). While VR is effective, the therapy is time consuming, not universally successful, and results in incomplete recovery by many patients. Work needs to be done in an attempt to improve therapy outcomes. This project will study the use of neuromodulation (through stimulation of the tongue) as an adjuvant to improve the effectiveness of VR and reduce the time involved in VR. Given past work with variants on this minimal medical impact appliance, using the PoNS™ device to augment therapy may result in a significant improvement in VR outcomes. Given the enormous public health and military burden of mTBI, and given that dizziness is a major component often responsible for significant morbidity, this project has significant military and civilian impact and can be beneficial to those who suffer mTBI worldwide.
The CN-NINM intervention is an experimental regimen. It has been developed over the last 12 years at Tactile Communication and Neurorehabilitation Laboratory (TCNL) at the University of Wisconsin - Madison. All human subjects testing was performed under IRB approval. The PoNS™ is an experimental device that has been evolved over this same period at TCNL, and is not FDA approved. An Investigator's Brochure and attendant Safety Chart have been developed to satisfy requirements for an Investigational Device Exemption, and provide additional context with respect to the research proposed here.
The goal of this work is to test the effectiveness of this device with standard rehabilitation therapy on individuals who have operationally induced balance disorders from blunt or blast head trauma.
SPECIFIC OBJECTIVES:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PoNS™ device
Device: PoNS™ device
placebo device
Other: Placebo device
Placebo device
The PoNS™ device uses electrotactile waveform in conjunction with the Cranial Nerve - Non-Invasive NeuroModulation (CN-NINM) intervention. This involves using both balance and gait training methods to stabilize symptoms, regain balance \& gait, and affect the functional transfer of improved stability and mobility to activities of daily living. It is based on a body of work focused on developing the tongue-based human-machine interface and application of this technology for balance, vision, and auditory substitution and more recently as neuromodulation for brain rehabilitation after injury and disease.
Also known as: Portable Neuromodulation Stimulator, version 2.2
Change in Sensory Organization Test score
Posturography for Sensory Organization Test: Utilizing a computerized dynamic posturography (Neurocom Inc., Clackmas, OR) the sensory organization test (SOT) is conducted by measuring postural sway on a force plate under six different conditions as follows 1) Normal Stance eyes open, 2) Normal Stance with eyes closed, 3) Normal Stance with sway referenced visual surround, 4) Sway reference stance eyes open, 5) Sway reference stance with eyes closed, and 6) Sway reference stance with sway referenced vision. The SOT will conduct three trials in each condition and utilize the information to produce a computer generated objective score of balance/posture function. The exam takes less than ten minutes to produce.
Time frame: Change from Baseline SOT score at 3 months
Change in Vestibular-Ocular Reflex scores
VOR Tests: A Neuro Kinetics IPortal Video-oculography system (Neurokinetics Inc., Pittsburgh, PA) with a six degree of freedom accelerometer will be used to (1) document head thrust test findings qualitatively and (2) provide objective measurements of test results. The software will be configured for (1) detection of head thrusts of appropriate direction and orientation (re: earth vertical) and (2) real-time determination of performance parameters (VOR).
Time frame: Change from Baseline VOR score at 3 months
Change in Functional Gait Assessment Test scores
The Functional Gait Assessment Test (FGAT) is a 10 item gait task test in which each task is graded on a 0-3 scale with 0 indicating could not perform and 3 indicating performed without error. Grading is done by an experienced rater. The FGAT produces an ordinal score on a 0-30 point scale and is normed from previous civilian and military studies.
Time frame: Change from Baseline FGAT score at 3 months
Change in Dizziness Handicap Index scores
The Dizziness Handicap Index (DHI) is a well-validated self report the produces a score on a hundred-point scale.
Time frame: Change from Baseline DHI score at 3 months
Change in Activities specific Balance Confidence scale scores
The Activities specific Balance Confidence scale (ABC) is a 16 question survey in which individuals' answer how confident they are about being able to perform a balance related task on a 0%-100% scale. The questionnaire is scored by adding the percentages and dividing by 100% to arrive at a scaled score form 0-100.
Time frame: Change from Baseline ABC score at 3 months
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jul 2013, a primary completion of Sep 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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United States Naval Medical Center, San Diego