Hearing and Vestibular Disorders Clinical Trial
Official title:
The Use of the PoNS™ Device in the Treatment of Blunt and Blast Induced Vestibular Disorders
| Verified date | September 2020 |
| Source | United States Naval Medical Center, San Diego |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Head Injury from blunt or blast suffered within the lines of duty - Not meeting any of the exclusion criteria - Injury occurred 21 -365 days ago Exclusion Criteria: - History of a diagnosed balance disorder prior to injury - Going through board process before starting participation - Significant medical issues including but not limited to heart disease, pulmonary disease, autoimmune disorders, severe arthritis, etc. - Orthopedic injuries that prevent standing and walking - Age less than 18 or greater than 40 years of age |
| Country | Name | City | State |
|---|---|---|---|
| United States | Naval Medical Center, San Diego | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| United States Naval Medical Center, San Diego | The Geneva Foundation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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. | Change from Baseline FGAT score at 3 months | |
| Other | 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. | Change from Baseline DHI score at 3 months | |
| Other | 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. | Change from Baseline ABC score at 3 months | |
| Primary | 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. | Change from Baseline SOT score at 3 months | |
| Secondary | 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). | Change from Baseline VOR score at 3 months |