Rehab System for Vestibular Hypofunction

(MINDGAPS Trial)

Recruiting at 1 trial location

Overseen By Andy Kittelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Montana

Disqualifiers: Acute head injury, Stroke, Neurodegenerative disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop new standards for assessing inner ear function and mental health, particularly for individuals recovering from concussions or mild traumatic brain injuries (mTBI). It also evaluates the MINDGAPS system, which tracks progress during six weeks of physical therapy for inner ear issues. Participants will either undergo this therapy, known as Vestibular Rehabilitation Therapy (VRT), or help create baseline data on inner ear recovery. Veterans or active duty military personnel who can stand independently are encouraged to participate. However, individuals with recent or severe head injuries, neck spine disorders, or certain eye and neurological conditions should not join. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve recovery standards for many.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the MINDGAPS system is safe for tracking rehabilitation progress?

Research has shown that vestibular rehabilitation, a therapy designed to improve balance and reduce dizziness, is generally safe and manageable. Studies indicate it is particularly beneficial for individuals experiencing ongoing dizziness. This therapy helps the brain adapt to changes in the inner ear. Evidence suggests it can significantly reduce the risk of falls, making it a promising option for those with balance issues following a concussion or mild head injury. Overall, vestibular rehabilitation offers a low-risk method to manage and improve symptoms related to inner ear problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way of using technology to enhance vestibular physical therapy for individuals with vestibular hypofunction. Unlike traditional treatments that rely solely on physical exercises, this approach integrates the MINDGAPS decision support system, which helps tailor therapy to the patient's specific needs. By providing personalized guidance, this method has the potential to improve the effectiveness of rehabilitation and speed up recovery times.

What evidence suggests that the MINDGAPS system is effective for vestibular hypofunction?

Studies have shown that vestibular rehabilitation therapy (VRT) effectively treats balance problems and dizziness. For most people with inner ear issues, VRT improves balance and eases daily activities. It also reduces symptoms like dizziness and unsteadiness. Research on patients with vestibular hypofunction (when the inner ear isn't working properly) supports these benefits. In this trial, participants in the experimental arm will undergo 6 weeks of vestibular physical therapy guided by the MINDGAPS decision support system, which might enhance recovery outcomes. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for veterans or active duty military members who can stand on their own and consent for themselves. It's not for those currently in physical therapy for balance/dizziness, with recent severe head injuries, blindness, certain eye or neck conditions, history of stroke/neurodegenerative diseases, or brain tumors.

Inclusion Criteria

I am legally able to make my own health decisions.

Veteran or Active Duty Military Service Member

I can stand up on my own.

Exclusion Criteria

I have a spine disorder in my neck.

I have been diagnosed with artery problems in my neck.

Acute head injury within the previous 2 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a double-baseline assessment with no intervention

2 weeks

2 visits (in-person)

Treatment

6 weeks of vestibular physical therapy guided by the MINDGAPS system

6 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rehab

Trial Overview The study aims to set norms for inner ear function and psychological health measures and test the MINDGAPS system—a remote monitoring tool during rehab after concussions/mild Traumatic Brain Injury affecting vestibular health.

How Is the Trial Designed?

Group I: Rehab Experimental Treatment 1 Intervention

6 weeks of vestibular physical therapy guided by the use of the MINDGAPS decision support system

Group II: Observational Active Control 1 Intervention

Normative data development of performance on vestibular measures following mTBI

Rehab is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Vestibular Rehabilitation Therapy for:

• Inner ear disorders
• Concussion and post-concussion syndrome
• Traumatic brain injury
• Vestibular migraines
• Benign paroxysmal positional vertigo (BPPV)
• Meniere’s disease
• Persistent postural-perceptual dizziness (PPPD)

Approved in Canada as Vestibular Rehabilitation Therapy for:

• Inner ear disorders
• Concussion and post-concussion syndrome
• Traumatic brain injury
• Vestibular migraines
• Benign paroxysmal positional vertigo (BPPV)
• Meniere’s disease
• Persistent postural-perceptual dizziness (PPPD)

Approved in European Union as Vestibular Rehabilitation Therapy for:

• Inner ear disorders
• Concussion and post-concussion syndrome
• Traumatic brain injury
• Vestibular migraines
• Benign paroxysmal positional vertigo (BPPV)
• Meniere’s disease
• Persistent postural-perceptual dizziness (PPPD)

Who Is Running the Clinical Trial?

University of Montana

Lead Sponsor

Trials

29

Recruited

4,700+

United States Naval Medical Center, San Diego

Collaborator

Trials

110

Recruited

24,200+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Published Research Related to This Trial

Vestibular rehabilitation therapy (VRT) significantly improved dizziness in elderly patients with chronic vestibular dysfunction, as shown by a notable decrease in dizziness handicap inventory (DHI) scores after 8 weeks of therapy.

In a study of 33 patients over 60 years old, VRT exercises led to marked improvements in balance and function, particularly in those with abnormal canal paralysis, indicating its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation outcomes in the elderly with chronic vestibular dysfunction. Bayat, A., Pourbakht, A., Saki, N., et al.[2022]

Customized vestibular rehabilitation therapy (VRT) is an effective treatment for patients experiencing symptoms like vertigo, gaze instability, and balance issues due to vestibular dysfunction.

The paper outlines specific patient selection criteria and rehabilitation strategies for both unilateral and bilateral vestibular deficits, highlighting the strong evidence supporting VRT's efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy for the dizzy patient. Tee, LH., Chee, NW.[2022]

Vestibular Rehabilitation Therapy (VRT) is an effective treatment for many patients with vestibular disorders and balance dysfunctions, helping to improve their symptoms.

The paper outlines various assessment methods and treatment strategies for VRT, emphasizing its importance in managing balance-related issues in patients seeking help from otolaryngologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation therapy for the patient with dizziness and balance disorders. Girardi, M., Konrad, HR.[2005]

In a study of 69 patients with chronic unilateral vestibular hypofunction, vestibular rehabilitation therapy combined with Wii® therapy significantly reduced dizziness handicap, as shown by a decrease in the Dizziness Handicap Inventory score from a median of 40 to 24 (P<.0001).

The therapy also improved balance and visual stability, with the Dynamic Gait Index score increasing from a median of 21 to 23 and dynamic visual acuity improving from a median of 2 to 1, both with statistical significance (P<.0001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after vestibular rehabilitation and Wii® therapy in patients with chronic unilateral vestibular hypofunction. Verdecchia, DH., Mendoza, M., Sanguineti, F., et al.[2022]

In a study of 74 participants with chronic dizziness, those who received expert physiotherapist guidance in a home-based vestibular rehabilitation therapy (VRT) program showed significantly greater improvement in their dizziness scores compared to those who exercised without specific instructions.

Both groups improved over the 8-week study, but the intervention group experienced a more substantial reduction in their Dizziness Handicap Inventory scores, highlighting the importance of tailored instructions for maximizing the effectiveness of home exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific and individualized instructions improve the efficacy of booklet-based vestibular rehabilitation at home - a randomized controlled trial (RCT). Kellerer, S., Amberger, T., Schlick, C., et al.[2023]

In a retrospective study of 32 patients, closely monitored vestibular rehabilitation therapy significantly improved balance and gait, as measured by the Dynamic Gait Index, compared to home exercise programs.

Patients receiving closely monitored therapy had a mean improvement of 7.83 points on the Dynamic Gait Index, while those doing home exercises improved by only 2.79 points, indicating that supervised therapy may lead to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of close monitoring in vestibular rehabilitation therapy. Itani, M., Koaik, Y., Sabri, A.[2019]

A four-week home exercise program significantly improved balance performance and reduced self-rated handicap in 16 subjects with chronic vestibular disease, as measured by the Smart Balance Master and Dizziness Handicap Inventory.

While balance and self-rated handicap improved, the emotional aspect of the handicap did not show significant change, suggesting that addressing emotional issues may further enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between change in balance and self-reported handicap after vestibular rehabilitation therapy. Murray, K., Carroll, S., Hill, K.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8920012/

Vestibular Rehabilitation for Peripheral Vestibular Hypofunction For the majority of individuals, VPT results in improved balance, reduced symptom complaints, improved functional recovery including activities of daily living, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10938910/

Efficacy of vestibular rehabilitation and its facilitating and ... Customized vestibular rehabilitation improved dizziness and imbalance in several randomized controlled trials. In the present study, ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.040663

Impact of Vestibular Rehabilitation and Dual‐Task Training ... The evidence supports that VRT, can probably improve balance, and DTT may improve gait outcomes among survivors of late subacute and chronic stroke.

4. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/counter/pdf/10.1186/s12916-023-03029-9.pdf?utm_source=consensus

Vestibular rehabilitation therapy on balance and gait in ... VRT has been found to be effective in improving balance in patients with peripheral ves- tibular dysfunction [6, 7] and individuals with vestibular hypofunction ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S019607092500078X

Enhanced recovery in unilateral vestibular hypofunction Previous research has shown that VRT positively affects the recovery of patients with UVH [8], and it improves subjective symptoms, gait performance, balance, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK572153/

Vestibular Rehabilitation - StatPearls - NCBI Bookshelf - NIH Vestibular rehabilitation is an effective treatment of many disorders peripheral in origin and promising indications as a treatment for those of central origin ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3259492/

Vestibular Rehabilitation Therapy: Review of Indications ... Vestibular rehabilitation therapy (VRT) is an exercise-based treatment program designed to promote vestibular adaptation and substitution.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07210840?lastUpdPost=2020-01-16_

Comparison Between Traditional Vestibular Rehabilitation ... Studies suggest that VR is feasible, well-tolerated, and effective, particularly for patients with persistent or visually-induced dizziness [9, ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2830236

Emergency Department Vestibular Rehabilitation Therapy ... The findings of this trial suggest that ED vestibular therapy is feasible and may improve patient-reported dizziness symptoms over time.