MTBI - Mild Traumatic Brain InjuryNCT06683417
Effectiveness of VestAid App
A study testing Vestibular Rehabilitation Aid in people with MTBI - Mild Traumatic Brain Injury and Vestibular Disease, run by BlueHalo at 1 site in United States.
Trial summary
This multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation exercises. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- MTBI - Mild Traumatic Brain Injury, Vestibular Disease, Balance Deficits
- What is being tested?
- Vestibular Rehabilitation Aid
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 30 Dec 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Snellen visual acuity (corrected) greater than 20/40
- No more than 25dB hearing loss at 500,1000, 2000, and 4000 Hz
- Ability to detect 4.31 using Semmes-Weinstein monofilament at the lower extremity
- At least 40 degrees of neck yaw motion with only mild to moderate pain (6 or under on 0-10 numeric pain scale)
- Internet access at home
- No significant residual from past musculoskeletal or neuromuscular conditions
Show all 11Show fewer
- Ability ambulates unassisted
- Diagnosed with a concussion or inner ear problem the last 30 days
- Between 18-60 years of age
- Can read and understand English
- Has complaints of dizziness
Who cannot join
- Greater then 30 days since diagnosis of concussion/mTBI or inner ear problem
- No access to internet at home
- Younger than 18 years of age or older than 60 years of age
- Cannot read or understand English
- No complaints of dizziness and/or balance deficits
- Have significant neuropathy
- Cannot see tablet clearly at 1 meter
- Neck pain \>5 on a 10-point pain scale.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Susan L Whitney, DPT, PhD, NCS, ATC, FAPTA, 412-383-6642, whitney@pitt.edu
About this study
Official title: Vestibular Rehabilitation Aid (VestAid)
This multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation exercises.
- Conditions
- MTBI - Mild Traumatic Brain Injury, Vestibular Disease, Balance Deficits, Vestibular Disorders, Dizziness
- Being tested
- Vestibular Rehabilitation Aid, Standard of care vestibular rehabilitation
- Keywords
- mTBI, vestibular rehabilitation, vestibular disorder, technology, application, dizziness, balance disorder, image processing, eye gaze compliance, VOR
- Medical subject headings
- Brain Concussion, Vestibular Diseases, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation AidDevice
Also called VestAid
The tablet-based VestAid system was developed to repair, restore and maintain vestibular-ocular function that is impaired in patients post-mTBI.
Each participant\'s treating physical therapist will develop their own personalized exercise prescription. The physical therapist will be asked to recommend that the patients complete a home exercise program at least 2-3 times per day for 6 weeks. The exercise prescription will be placed on the VestAid by the physical therapist for the patient to follow. The patient is not able to modify the exercise, only the physical therapist can modify the exercises. Exercises will be modified based on patient\'s response and symptom reports. The physical therapist and study coordinator will receive an alert on the VestAid online dashboard if the patient\'s symptoms are greater than or equal to 8/10.
Standard of care vestibular rehabilitationOther
Vestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades
| Study group | Role | What they receive |
|---|---|---|
| VestAid | Experimental | Use of VestAid tablet application to aid vestibular rehabilitation Receives: Device: Vestibular Rehabilitation Aid |
| Standard of Care vestibular rehabilitation | Active comparator | Use of standard of care vestibular rehabilitation Receives: Other: Standard of care vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory (DHI)
A self report measure of dizziness (questionnaire)
Measured: From enrollment weekly for 6 weeks.
Secondary outcomes (1)
Secondary Endpoint
Subjective symptom reporting of dizziness, headache, nausea, and fogginess
Measured: From enrollment weekly for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start15 Jan 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MTBI - 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BlueHalo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683417
- Sponsor's protocol ID
- STUDY24060038
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Whitney SL, Sparto PJ. Principles of vestibular physical therapy rehabilitation. NeuroRehabilitation. 2011;29(2):157-66. doi: 10.3233/NRE-2011-0690.
PubMed 22027077Shepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9.
PubMed 7816453Gottshall K. Vestibular rehabilitation after mild traumatic brain injury with vestibular pathology. NeuroRehabilitation. 2011;29(2):167-71. doi: 10.3233/NRE-2011-0691.
PubMed 22027078Hall 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 16796772Essery R, Geraghty AW, Kirby S, Yardley L. Predictors of adherence to home-based physical therapies: a systematic review. Disabil Rehabil. 2017 Mar;39(6):519-534. doi: 10.3109/09638288.2016.1153160. Epub 2016 Apr 21.
PubMed 27097761Mucha A, Collins MW, Elbin RJ, Furman JM, Troutman-Enseki C, DeWolf RM, Marchetti G, Kontos AP. A Brief Vestibular/Ocular Motor Screening (VOMS) assessment to evaluate concussions: preliminary findings. Am J Sports Med. 2014 Oct;42(10):2479-86. doi: 10.1177/0363546514543775. Epub 2014 Aug 8.
PubMed 25106780
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Rehabilitation Aid (VestAid)
- ClinicalTrials.gov ID
- NCT06683417
- Acronym / sponsor ID
- STUDY24060038
- Conditions
- MTBI - Mild Traumatic Brain Injury, Vestibular Disease, Balance Deficits, Vestibular Disorders, Dizziness
- Keywords
- mTBI, vestibular rehabilitation, vestibular disorder, technology, application, dizziness, balance disorder, image processing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- BlueHaloIndustry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Nov 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.
This multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VestAid | Experimental | Device: Vestibular Rehabilitation AidUse of VestAid tablet application to aid vestibular rehabilitation |
| Standard of Care vestibular rehabilitation | Active comparator | Other: Standard of care vestibular rehabilitationUse of standard of care vestibular rehabilitation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Snellen visual acuity (corrected) greater than 20/40
- No more than 25dB hearing loss at 500,1000, 2000, and 4000 Hz
- Ability to detect 4.31 using Semmes-Weinstein monofilament at the lower extremity
- At least 40 degrees of neck yaw motion with only mild to moderate pain (6 or under on 0-10 numeric pain scale)
- Internet access at home
Key exclusion criteria (8 listed)
- Greater then 30 days since diagnosis of concussion/mTBI or inner ear problem
- No access to internet at home
- Younger than 18 years of age or older than 60 years of age
- Cannot read or understand English
- No complaints of dizziness and/or balance deficits
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 AidAlso: VestAidThe tablet-based VestAid system was developed to repair, restore and maintain vestibular-ocular function that is impaired in patients post-mTBI. Each participant\'s treating physical therapist will develop their own personalized exercise prescription. The physical therapist will be asked to recommend that the patients complete a home exercise program at least 2-3 times per day for 6 weeks. The exercise prescription will be placed on the VestAid by the physical therapist for the patient to follow. The patient is not able to modify the exercise, only the physical therapist can modify the exercises. Exercises will be modified based on patient\'s response and symptom reports. The physical therapist and study coordinator will receive an alert on the VestAid online dashboard if the patient\'s symptoms are greater than or equal to 8/10. | Device | VestAid |
| Standard of care vestibular rehabilitationVestibular rehabilitation to include gaze stabilization exercises, optokinetic training, smooth pursuits and saccades | Other | Standard of Care vestibular rehabilitation |
Primary outcome
Dizziness Handicap Inventory (DHI)
Time frame: From enrollment weekly for 6 weeks.
A self report measure of dizziness (questionnaire)
1 secondary outcome
Secondary Endpoint
Time frame: From enrollment weekly for 6 weeks
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 12 Nov 2024.
- Background: PubMed 22027077Whitney SL, Sparto PJ. Principles of vestibular physical therapy rehabilitation. NeuroRehabilitation. 2011;29(2):157-66. doi: 10.3233/NRE-2011-0690.
- Background: PubMed 7816453Shepard NT, Telian SA. Programmatic vestibular rehabilitation. Otolaryngol Head Neck Surg. 1995 Jan;112(1):173-82. doi: 10.1016/S0194-59989570317-9.
- Background: PubMed 22027078Gottshall K. Vestibular rehabilitation after mild traumatic brain injury with vestibular pathology. NeuroRehabilitation. 2011;29(2):167-71. doi: 10.3233/NRE-2011-0691.
- 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 27097761Essery R, Geraghty AW, Kirby S, Yardley L. Predictors of adherence to home-based physical therapies: a systematic review. Disabil Rehabil. 2017 Mar;39(6):519-534. doi: 10.3109/09638288.2016.1153160. Epub 2016 Apr 21.
- Background: PubMed 25106780Mucha A, Collins MW, Elbin RJ, Furman JM, Troutman-Enseki C, DeWolf RM, Marchetti G, Kontos AP. A Brief Vestibular/Ocular Motor Screening (VOMS) assessment to evaluate concussions: preliminary findings. Am J Sports Med. 2014 Oct;42(10):2479-86. doi: 10.1177/0363546514543775. Epub 2014 Aug 8.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation Aid in people with MTBI - Mild Traumatic Brain Injury and Vestibular Disease, run by BlueHalo at 1 site 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 11 inclusion and 8 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: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Susan L Whitney, DPT, PhD, NCS, ATC, FAPTA (412-383-6642, whitney@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (DHI) (time frame: From enrollment weekly for 6 weeks.). 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 NCT06683417, which also lists 6 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 12 Nov 2024.