An interventional study of Generalized Vestibular Rehabilitation Treatment and Individualized Vestibular Rehabilitation Treatment in Vestibular Problem and Traumatic Brain Injury, sponsored by The Defense and Veterans Brain Injury Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2022-03-24.
Sponsored by The Defense and Veterans Brain Injury Center · 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 12th largest by enrollment of the 48 interventional ones that give a count, is one of 4 that started in 2018, is one of 44 with no phase, and was the 16th 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 49 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. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 62 is above the median of 46 across 127 interventional studies indexed under Vestibular Diseases.
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:
The Defense and Veterans Brain Injury Center is the lead sponsor of 6 studies on the registry; none are open to participants now.
The Defense and Veterans Brain Injury Center 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.
To prospectively evaluate the tools, environment and resources to compare the effectiveness of two different standard of care vestibular rehabilitation approaches in a military cohort with post-concussive vestibular symptoms.
Aim 1. To prospectively evaluate the reliability of a series of diagnostic and outcome assessment tools in a military cohort with post-concussive vestibular symptoms; these to include the Dizziness Handicap Inventory (DHI), Activities-Specific Balance Confidence Scale (ABC), the Computerized Dynamic Posturography (CDP) and the Neuro-Otologic Test System (NOTC).
Hypothesis 1. Active military personnel consist of physically high functioning individuals in whom standard diagnostic and outcome assessment tools may fail to target variations in performance. The investigators believe that active military personnel score different than general populations in standard diagnostic and outcome assessment tools.
Endpoint 1. The investigators will compare the DHI, ABC, CDP and NOTC results obtained in this study with historical data from the studies supporting the validation of each of the individual assessment tools.
Aim 2. To assess the concept of 'clinically meaningful change' as it relates to dizziness specific to a military cohort with post-concussive vestibular symptoms.
Hypothesis 2. Because of the differences in physical characteristics and performance demands between active duty military personnel and the general population, it is difficult to define if changes in diagnostic and outcome assessment evaluations in the military population reflect worsening or progression of symptoms at the same rate and magnitude observed in the general population.
Endpoint 2. The investigators will establish a comparison among study test results (DHI, ABC, CDP and NOTC) and compare these to clinical measures of response to treatment (Neurobehavioral Symptom Inventory - vestibular domain and Patients' Global Impression of Change Scale) to identify the rate and magnitude of change in the military cohort.
Aim 3. To compare scoring differences between subjects receiving individualized vestibular rehabilitation treatment (IVRT) and subjects receiving generalized vestibular rehabilitation treatment (GVRT), and to calculate the magnitude of change or the lack of it to determine the sample size for a subsequent comparative effectiveness trial.
Hypothesis 3. The combination of tests used in this study has not been used before; therefore, no data is available to calculate the sample size needed to determine comparative effectiveness between GVRT vs IVRT using DHI, ABC, CDP and NOTC.
Endpoint 3. The investigators will compare DHI, ABC, CDP and NOTC measurement results between treatment groups to estimate normal variation.
Aim 4. To refine methods, procedures, and information parameters for a comparative effectiveness trial assessing individualized vs. generalized vestibular rehabilitation therapy.
Endpoint 4. The investigators will evaluate and compare different elements inherent to the trial such as mechanisms of subject identification, evaluation times and tolerance, information tracking, etc. along with data obtained through the Patient Satisfaction Survey (PSS).
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Exclusion Criteria:
Randomized Generalized Vestibular Rehabilitation Treatment (8 treatments) as part of standard of care (not research visits)
Other: Generalized Vestibular Rehabilitation Treatment
Randomized Individualized Vestibular Rehabilitation Treatment (3 treatments) as part of standard of care (not research visits)
Other: Individualized Vestibular Rehabilitation Treatment
These treatment visits are available twice a week and each visit lasts 45 minutes. Individuals receiving GVRT are allowed to choose the frequency at which they want to attend and the program is designed for each subject to complete 8 visits within a period between 4 and 8 weeks. The ideal number of patients receiving treatment at each class is from 3 to 6 but the system has capacity for a maximum of 8. GVRT is a standard of care treatment option and is not considered research.
Also known as: GVRT
Individuals receiving IVRT are scheduled depending on their individual needs and PT availability. These visits require one-on-one time with a PT. Individuals are commonly seen by the PT 3 times at two week intervals. These visits last 30 minutes and include PT evaluation designed to instruct patients on exercises for them to perform on their own. IVRT is a standard of care treatment option and is not considered research.
Also known as: IVRT
Change in Dizziness Handicap Inventory (DHI) score
Self reported perception of handicap related to dizziness. 25 questions. Each item is scored 0 - 4 (0 = no, 2 = sometimes, 4 = always), yielding a total score between 0 (no perceived disability) and 100 (maximum perceived disability). Subscales related to certain questions are describes as physical, emotional and functional disabilities.
Time frame: Baseline and 2 weeks after final treatment visit
Change in Activities-specific Balance Confidence (ABC) Scale
Self reported level of confidence of not losing balance or becoming unsteady during specific activities. Participants rate their perceived confidence on a 0-100% scale (0% = no confidence, 100% = completely confident). Total score is averaged percentage of 16 questions.
Time frame: Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score on Sensory Organization Test (SOT)
Equilibrium score quantifies postural stability during each of 3 trials of 6 sensory conditions obtained via Computerized Dynamic Posturography (CDP). Equilibrium is scored between 0 and 100 (0 = worst, 100 best).
Time frame: Baseline and 2 weeks after final treatment visit
Change in Composite Equilibrium Score on Sensory Organization Test (SOT)
Composite Equilibrium Score is averaged from the six SOT Equilibrium Scores. Equilibrium score quantifies postural stability during each of 3 trials of 6 sensory conditions obtained via Computerized Dynamic Posturography (CDP). Equilibrium is scored between 0 and 100 (0 = worst, 100 best).
Time frame: Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score on Horizontal Head-Shake Sensory Organization Test (HS-SOT)
Equilibrium score quantifies postural stability with horizontal head movement during each of 3-4 trials of 2 sensory conditions obtained via Computerized Dynamic Posturography (CDP). Equilibrium is scored between 0 and 100 (0 = worst, 100 best).
Time frame: Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score Ratio (SOT and Horizontal HS-SOT)
Equilibrium Score Ratio compares the average Equilibrium Score between the SOT and HS-SOT relating to the same sensory conditions. Equilibrium score quantifies postural stability during each of 3-4 trials of 2 sensory conditions obtained via Computerized Dynamic Posturography (CDP). Equilibrium is scored between 0 and 100 (0 = worst, 100 best).
Time frame: Baseline and 2 weeks after final treatment visit
Change in logMAR (Visual Acuity) during horizontal head movement (Dynamic Visual Acuity)
logMAR is given for positive and negative responses during left movement and right movement. logMAR is a unit describing the apparent size of an image based on a ratio of its absolute size to distance from the eye.
Time frame: Baseline and 2 weeks after final treatment visit
Change in logMAR (Visual Acuity) during vertical head movement (Dynamic Visual Acuity)
logMAR is given for positive and negative responses during up movement and down movement. logMAR is a unit describing the apparent size of an image based on a ratio of its absolute size to distance from the eye.
Time frame: Baseline and 2 weeks after final treatment visit
Change in Neuro-Otologic Testing
Gaze Horizontal, Random Saccades Horizontal and Vertical, Smooth Pursuit Horizontal 0.1Hz and 0.75Hz, Smooth Pursuit Vertical 0.1Hz and 0.75Hz, Predictive Saccades Horizontal, Antisaccades, OKN Trap 20deg/sec and 60deg/sec, Visual Reaction Time, Saccade and Reaction Time, Auditory Reaction Time, Chair Rotation Sinusoidal 0.02Hz, 0.08Hz and 0.64Hz, Visual Enhancement, Visual Suppression, Step Test, Subjective Visual Vertical, crHIT
Time frame: Baseline and 2 weeks after final treatment visit
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Jun 2020, 27 months.
Of 79 non-industry interventional studies with no phase under Vestibular Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 27 months is above that.
Counting every sponsor, half of 84 studies reached it within 15 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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The Defense and Veterans Brain Injury Center