Mild Traumatic Brain InjuryNCT06222450
Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI
A study testing Vestibular Rehabilitation Therapy (VRT) in people with Mild Traumatic Brain Injury and Dizziness, run by Mountain Home Research & Education Corporation at 3 sites in United States.
Trial summary
The goal of this clinical trial is to compare outcomes for standard vestibular rehabilitation home program to a digital vestibular rehabilitation home program in adults with dizziness related to mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury, Dizziness
- What is being tested?
- Vestibular Rehabilitation Therapy (VRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age,
- diagnosis of mTBI,
- documented dizziness (total DHI score ≥ 16) and/or imbalance (total functional gait assessment score < 23/30 or < age-referenced norms)
Who cannot join
- severe neurological disease (e.g., Parkinson's disease, neuropathy),
- moderate to severe cognitive impairment (< 23/30 on the Montreal Cognitive Assessment),
- significant orthopedic issues that would impact mobility or ability to perform gaze stabilization exercises (e.g., significant cervical dysfunction or pain),
- vision impairment (best-corrected visual acuity worse than 20/40 in the better eye), and
- severe depression/anxiety (≥ 9 on the 4-item Patient health Questionnaire)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Duke University School of Medicine
Durham, North Carolina, 27710
Kristal Riska, PhD, 919-681-9458, kristal.riska@duke.edu
Kristal Riska
- Recruiting
James H Quillen VAMC
Mountain Home, Tennessee, 37684
Stephanie Panoncillo, 423-926-1171 ext. 2116, stephanie.panoncillo@va.gov
Courtney Hall
- Recruiting
James A Haley VA Hospital
Tampa, Florida, 33612
Jemy Delikat, 813-972-2000 ext. 3955, jemy.delikat@va.gov
Karen Skop
About this study
Official title: Rock Steady: A Mobile, Gamified Vestibular Rehabilitation Therapy App for Adults With Dizziness Related to Mild Traumatic Brain Injury
The goal of this clinical trial is to compare outcomes for standard vestibular rehabilitation home program to a digital vestibular rehabilitation home program in adults with dizziness related to mild traumatic brain injury (mTBI). The main question is whether participants who use the digital format of vestibular rehabilitation improve to a greater extent at discharge than those who use the standard format. Participants will undergo a customized vestibular rehabilitation home exercise program per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training under the supervision of a physical therapist. Participants will complete the gaze stabilization and habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks.
Participants will be tested before and after the 4-week intervention. At the initial session, the researcher will perform standard clinical tests of the inner ear balance system. Also at the initial session, the researcher will perform standard clinical tests of balance and walking and questionnaires about the impact of dizziness on daily activities. At the final session, the researcher will repeat the tests of balance and walking and questionnaires. Three months after completing the intervention participants will complete an online questionnaire about the impact of dizziness on daily activities.
Read the detailed description
A single blind randomized controlled trial (RCT) will be performed with pre- and post-treatment assessment and a 3-month follow-up assessment. Study groups are defined by the method that the home exercise vestibular rehabilitation therapy (VRT) program is provided: Group 1 will receive standard vestibular rehabilitation therapy (S-VRT) home program, while Group 2 will receive a digital vestibular rehabilitation therapy (D-VRT) home program using the Health in Motion platform. Sixty-eight adults (+10% for attrition) with sub-acute (2 weeks-3 months) or chronic dizziness (> 3 months) related to mTBI will be recruited and enrolled in the study. We will use a randomized block design to assure equal allocation of symptom severity to the intervention groups. Random assignment will be made using SPSS random number function. The research coordinator at each study site will create sealed study envelopes with the random study identification number that contains group assignment. In order to instruct the participant in the appropriate exercise intervention, the treating physical therapist will receive an envelope (in consecutive order) once a subject has consented to participate in the study. This study will incorporate a single blind research design, so that the researcher performing clinical balance and gait assessments will be blinded to group assignment. It is not possible to blind the treating therapist or participants.
During the pre-test session, the researcher will perform a standard vestibular evaluation including tests of balance and walking as well as questionnaires about dizziness impact on activities, balance confidence, motion sensitivity, and disability.
The treating clinician will create and provide a customized VRT home exercise program (HEP) per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training. Gaze stabilization exercises involve head movement while maintaining fixation on a target which may be stationary or moving. Habituation exercises are chosen based on movements (of self or the visual environment) that provoke symptoms and the participant performs several repetitions of motions that cause mild to moderate symptoms. Balance and gait exercises are chosen based on identified impairments and limitations and are performed under challenging sensory and dynamic conditions to optimize balance. General conditioning, such as a customized graduated walking program for endurance will be included.
All participants will receive verbal instructions (in Health in Motion the text instruction is accompanied with voice over), demonstration of, and feedback on, accurate performance of the gaze stabilization/habituation HEP per group assignment. The S-VRT group will only receive these instructions and feedback at the weekly clinic visit from the supervising clinician. The D-VRT group will receive exercise instructions and demonstration via the Rock Steady app the first time using a game and as requested thereafter. The supervising clinician will evaluate the participant's ability to accurately perform the exercises at each follow-up visit (1x/week) and will provide additional training/feedback as needed for both S-VRT and D-VRT groups.
All participants will be instructed to complete the gaze stabilization/habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks. All participants will use a paper exercise log to record the performance of the HEP, regardless of group assignment. After completing the 4-week intervention, participants will be offered the option to continue using their current method or try the alternate method for the 3- month maintenance phase. After the 3-month maintenance phase, participants will complete the questionnaire about dizziness impact on daily activities.
- Conditions
- Mild Traumatic Brain Injury, Dizziness
- Being tested
- Vestibular Rehabilitation Therapy (VRT)
- Keywords
- vestibular rehabilitation, digital health, remote therapeutic monitoring
- Medical subject headings
- Brain Concussion, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation Therapy (VRT)Behavioural
customized VRT home exercise program per standard of care, includes gaze stabilization, habituation, balance and gait exercises, and endurance training
| Study group | Role | What they receive |
|---|---|---|
| Standard VRT | Active comparator | The gaze stabilization, habituation and balance/gait HEP will be delivered using standard paper handouts Receives: Behavioral: Vestibular Rehabilitation Therapy (VRT) |
| Digital VRT | Experimental | The gaze stabilization, habituation and balance/gait HEP will be delivered using a digital home program using the Health in Motion platform Receives: Behavioral: Vestibular Rehabilitation Therapy (VRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Dizziness on the Dizziness Handicap Inventory (DHI) at week four and week 12
The DHI is a self-report scale of the impact of dizziness on activities (Jacobson \& Newman, 1990). Total scores range from 0 (no handicap) to 100 (severe handicap).
Measured: baseline, week 4, week 12
Secondary outcomes (7)
Change from baseline in modified Clinical Test of Sensory Interaction and Balance (mCTSIB) at week 4
The mCTSIB assesses sensory integration by measuring postural stability under conditions in which visual and somatosensory feedback is altered. The test is organized into a series of four conditions of increasing difficulty. The first two conditions are performed on a firm surface with eyes open and eyes closed. The final two conditions are performed on a foam surface with eyes open and closed. The maximum duration of each trial is 30 seconds. The total score is the sum of the four conditions with a maximum total of 120 seconds.
Measured: baseline, week 4
Change from baseline in Functional Gait Assessment (FGA) at week 4
The FGA tests dynamic gait. The FGA is a 10-item test that incorporates more difficult gait items, e.g., head turns, narrow base of support, backwards, and with eyes closed (Wrisley et al., 2004). Total FGA scores < 23/30 indicate high fall risk and there are age-referenced norms for comparison (Walker et al., 2007).
Measured: baseline, week 4
Change from baseline in 10 Meter Walk Test (10MWT) at week 4
The (10MWT) will be used to assess preferred gait speed (Bohannon \& Williams, 2011). Participants will walk at their normal pace on a level, 10-meter walkway. The dependent variable is preferred gait speed (m/s).
Measured: baseline, week 4
Change from baseline in Visual Analogue Scales (VAS) at week 4
The VAS quantifies the impact of dizziness on activities. Participants place a mark on a 10-cm horizontal line with 20% increments indicated (0-100%; Hall \& Herdman, 2006). Patients indicate the percent of time that dizziness interferes with activities.
Measured: baseline, week 4
Change from baseline in Activities-specific Balance Confidence scale (ABC) at week 4
The ABC measures individuals' confidence that they can maintain balance in a variety of situations (Powell \& Myers, 1995). The ABC was developed to assess balance confidence across a continuum of activities. An overall score is calculated and lower scores indicate worse confidence in balance ability.
Measured: baseline, week 4
Change from baseline in Disability Rating Scale (DRS) at week 4
The DRS is a self-report measure of the overall impact of dizziness on activities (Shepard et al., 1990). The scale involves a 6-point rating scale with 0 indicating no disability and 5 indicating long-term severe disability.
Measured: baseline, week 4
Change from baseline in modified Motion Sensitivity Test (mMST) at week 4
The mMST is a a measure of is a measure of motion-provoked dizziness. The test involves ten quick movements that are performed in standing and after each movement is completed, the intensity and duration of symptoms are recorded (Heusel-Gillig et al., 2022). A total score is calculated and can range from 0 to 100 with higher scores indicating greater motion sensitivity.
Measured: baseline, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Dec 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mountain Home Research & Education Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222450
- Sponsor's protocol ID
- TP210512
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will comply with VA policy regarding the dissemination of de-identified data collected from participants consenting to Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system and the FDA. We will make available descriptive data on device accuracy and effectiveness.
Publications
Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
PubMed 2317323Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.
PubMed 15449976Walker ML, Austin AG, Banke GM, Foxx SR, Gaetano L, Gardner LA, McElhiney J, Morris K, Penn L. Reference group data for the functional gait assessment. Phys Ther. 2007 Nov;87(11):1468-77. doi: 10.2522/ptj.20060344. Epub 2007 Sep 4.
PubMed 17785375Bohannon RW, Williams Andrews A. Normal walking speed: a descriptive meta-analysis. Physiotherapy. 2011 Sep;97(3):182-9. doi: 10.1016/j.physio.2010.12.004. Epub 2011 May 11.
PubMed 21820535Hall CD, Herdman SJ. Reliability of clinical measures used to assess patients with peripheral vestibular disorders. J Neurol Phys Ther. 2006 Jun;30(2):74-81. doi: 10.1097/01.npt.0000282571.55673.ed.
PubMed 16796772Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
PubMed 7814786Shepard NT, Telian SA, Smith-Wheelock M. Habituation and balance retraining therapy. A retrospective review. Neurol Clin. 1990 May;8(2):459-75.
PubMed 2359384Heusel-Gillig L, Santucci V, Hall CD. Development and Validation of the Modified Motion Sensitivity Test. Otol Neurotol. 2022 Sep 1;43(8):944-949. doi: 10.1097/MAO.0000000000003641.
PubMed 35970158
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rock Steady: A Mobile, Gamified Vestibular Rehabilitation Therapy App for Adults With Dizziness Related to Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06222450
- Acronym / sponsor ID
- TP210512
- Conditions
- Mild Traumatic Brain Injury, Dizziness
- Keywords
- vestibular rehabilitation, digital health, remote therapeutic monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Mountain Home Research & Education CorporationUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare outcomes for standard vestibular rehabilitation home program to a digital vestibular rehabilitation home program in adults with dizziness related to mild traumatic brain injury (mTBI). The main question is whether participants who use the digital format of vestibular rehabilitation improve to a greater extent at discharge than those who use the standard format. Participants will undergo a customized vestibular rehabilitation home exercise program per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training under the supervision of a physical therapist. Participants will complete the gaze stabilization and habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks.
Participants will be tested before and after the 4-week intervention. At the initial session, the researcher will perform standard clinical tests of the inner ear balance system. Also at the initial session, the researcher will perform standard clinical tests of balance and walking and questionnaires about the impact of dizziness on daily activities. At the final session, the researcher will repeat the tests of balance and walking and questionnaires. Three months after completing the intervention participants will complete an online questionnaire about the impact of dizziness on daily activities.
Detailed description
A single blind randomized controlled trial (RCT) will be performed with pre- and post-treatment assessment and a 3-month follow-up assessment. Study groups are defined by the method that the home exercise vestibular rehabilitation therapy (VRT) program is provided: Group 1 will receive standard vestibular rehabilitation therapy (S-VRT) home program, while Group 2 will receive a digital vestibular rehabilitation therapy (D-VRT) home program using the Health in Motion platform. Sixty-eight adults (+10% for attrition) with sub-acute (2 weeks-3 months) or chronic dizziness (> 3 months) related to mTBI will be recruited and enrolled in the study. We will use a randomized block design to assure equal allocation of symptom severity to the intervention groups. Random assignment will be made using SPSS random number function. The research coordinator at each study site will create sealed study envelopes with the random study identification number that contains group assignment. In order to instruct the participant in the appropriate exercise intervention, the treating physical therapist will receive an envelope (in consecutive order) once a subject has consented to participate in the study. This study will incorporate a single blind research design, so that the researcher performing clinical balance and gait assessments will be blinded to group assignment. It is not possible to blind the treating therapist or participants.
During the pre-test session, the researcher will perform a standard vestibular evaluation including tests of balance and walking as well as questionnaires about dizziness impact on activities, balance confidence, motion sensitivity, and disability.
The treating clinician will create and provide a customized VRT home exercise program (HEP) per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training. Gaze stabilization exercises involve head movement while maintaining fixation on a target which may be stationary or moving. Habituation exercises are chosen based on movements (of self or the visual environment) that provoke symptoms and the participant performs several repetitions of motions that cause mild to moderate symptoms. Balance and gait exercises are chosen based on identified impairments and limitations and are performed under challenging sensory and dynamic conditions to optimize balance. General conditioning, such as a customized graduated walking program for endurance will be included.
All participants will receive verbal instructions (in Health in Motion the text instruction is accompanied with voice over), demonstration of, and feedback on, accurate performance of the gaze stabilization/habituation HEP per group assignment. The S-VRT group will only receive these instructions and feedback at the weekly clinic visit from the supervising clinician. The D-VRT group will receive exercise instructions and demonstration via the Rock Steady app the first time using a game and as requested thereafter. The supervising clinician will evaluate the participant's ability to accurately perform the exercises at each follow-up visit (1x/week) and will provide additional training/feedback as needed for both S-VRT and D-VRT groups.
All participants will be instructed to complete the gaze stabilization/habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks. All participants will use a paper exercise log to record the performance of the HEP, regardless of group assignment. After completing the 4-week intervention, participants will be offered the option to continue using their current method or try the alternate method for the 3- month maintenance phase. After the 3-month maintenance phase, participants will complete the questionnaire about dizziness impact on daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard VRT | Active comparator | Behavioral: Vestibular Rehabilitation Therapy (VRT)The gaze stabilization, habituation and balance/gait HEP will be delivered using standard paper handouts |
| Digital VRT | Experimental | Behavioral: Vestibular Rehabilitation Therapy (VRT)The gaze stabilization, habituation and balance/gait HEP will be delivered using a digital home program using the Health in Motion platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age,
- diagnosis of mTBI,
- documented dizziness (total DHI score ≥ 16) and/or imbalance (total functional gait assessment score < 23/30 or < age-referenced norms)
Key exclusion criteria (5 listed)
- severe neurological disease (e.g., Parkinson's disease, neuropathy),
- moderate to severe cognitive impairment (< 23/30 on the Montreal Cognitive Assessment),
- significant orthopedic issues that would impact mobility or ability to perform gaze stabilization exercises (e.g., significant cervical dysfunction or pain),
- vision impairment (best-corrected visual acuity worse than 20/40 in the better eye), and
- severe depression/anxiety (≥ 9 on the 4-item Patient health Questionnaire)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Rehabilitation Therapy (VRT)customized VRT home exercise program per standard of care, includes gaze stabilization, habituation, balance and gait exercises, and endurance training | Behavioural | Digital VRT, Standard VRT |
Primary outcome
Change from baseline in Dizziness on the Dizziness Handicap Inventory (DHI) at week four and week 12
Time frame: baseline, week 4, week 12
The DHI is a self-report scale of the impact of dizziness on activities (Jacobson \& Newman, 1990). Total scores range from 0 (no handicap) to 100 (severe handicap).
7 secondary outcomes
Change from baseline in modified Clinical Test of Sensory Interaction and Balance (mCTSIB) at week 4
Time frame: baseline, week 4
Change from baseline in Functional Gait Assessment (FGA) at week 4
Time frame: baseline, week 4
Change from baseline in 10 Meter Walk Test (10MWT) at week 4
Time frame: baseline, week 4
Change from baseline in Visual Analogue Scales (VAS) at week 4
Time frame: baseline, week 4
Change from baseline in Activities-specific Balance Confidence scale (ABC) at week 4
Time frame: baseline, week 4
Change from baseline in Disability Rating Scale (DRS) at week 4
Time frame: baseline, week 4
Change from baseline in modified Motion Sensitivity Test (mMST) at week 4
Time frame: baseline, week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 2317323Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
- Background: PubMed 15449976Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.
- Background: PubMed 17785375Walker ML, Austin AG, Banke GM, Foxx SR, Gaetano L, Gardner LA, McElhiney J, Morris K, Penn L. Reference group data for the functional gait assessment. Phys Ther. 2007 Nov;87(11):1468-77. doi: 10.2522/ptj.20060344. Epub 2007 Sep 4.
- Background: PubMed 21820535Bohannon RW, Williams Andrews A. Normal walking speed: a descriptive meta-analysis. Physiotherapy. 2011 Sep;97(3):182-9. doi: 10.1016/j.physio.2010.12.004. Epub 2011 May 11.
- Background: PubMed 16796772Hall CD, Herdman SJ. Reliability of clinical measures used to assess patients with peripheral vestibular disorders. J Neurol Phys Ther. 2006 Jun;30(2):74-81. doi: 10.1097/01.npt.0000282571.55673.ed.
- Background: PubMed 7814786Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
- Background: PubMed 2359384Shepard NT, Telian SA, Smith-Wheelock M. Habituation and balance retraining therapy. A retrospective review. Neurol Clin. 1990 May;8(2):459-75.
- Background: PubMed 35970158Heusel-Gillig L, Santucci V, Hall CD. Development and Validation of the Modified Motion Sensitivity Test. Otol Neurotol. 2022 Sep 1;43(8):944-949. doi: 10.1097/MAO.0000000000003641.
- Individual participant dataSharing planned: No. We will comply with VA policy regarding the dissemination of de-identified data collected from participants consenting to Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system and the FDA. We will make available descriptive data on device accuracy and effectiveness.
Related trials for Mild Traumatic Brain Injury
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation Therapy (VRT) in people with Mild Traumatic Brain Injury and Dizziness, run by Mountain Home Research & Education Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Hall (423-926-1171 ext. 7518, hallcd1@etsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Dizziness on the Dizziness Handicap Inventory (DHI) at week four and week 12 (time frame: baseline, week 4, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06222450, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.