What side effects are associated with this type of intervention?

Vestibular hypofunction treatments often include vestibular rehabilitation therapy (VRT), which can be monitored remotely as in the MINDGAPS system. Common side effects of VRT may include temporary dizziness, nausea, and imbalance as the body adjusts to the exercises. These symptoms are generally mild and decrease as therapy progresses. Remote monitoring systems like MINDGAPS aim to track progress and adjust therapy to minimize these side effects while maximizing rehabilitation benefits.

What prior FDA approvals exist?

FDA-approved treatments for Vestibular Hypofunction primarily include medications like betahistine, which has shown efficacy in reducing dizziness and vertigo. The MINDGAPS system, which is a remote monitoring tool for tracking rehabilitation progress, represents a novel approach focusing on physical therapy and psychological health rather than pharmacological intervention. This system aims to improve inner ear function and overall vestibular health through continuous monitoring and tailored rehabilitation programs.

What other types of research exist?

Promising alternatives to the MINDGAPS system for remote monitoring of vestibular hypofunction patients include: 1) Kinect-based rehabilitation systems, which utilize contactless sensing and dynamic programming techniques for home-based exercises; 2) Telemedicine platforms that offer comprehensive remote monitoring and management of chronic conditions; and 3) Advanced wearable devices that provide continuous tracking of vestibular function and patient activity levels. These alternatives leverage readily available technology and have shown potential in preliminary studies.

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Behavioural Intervention

Rehab System for Vestibular Hypofunction (MINDGAPS Trial)

N/A

Recruiting

Research Sponsored by University of Montana

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the MINDGAPS system, a remote tool to help active-duty and Veteran Service Members with balance and psychological issues after a mild brain injury. It measures balance and visual stability to tailor treatments and track improvements. The goal is to enhance both physical and mental health in this specific group.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves rehabilitation exercises rather than medication, side effects may include temporary discomfort or dizziness during the exercises but will vary based on individual tolerance to physical therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Computerized Dynamic Visual Acuity (cDVA)

Secondary study objectives

Dizziness Handicap Inventory (DHI)

Functional Gait Assessment (FGA)

General Well Being Scale

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RehabExperimental Treatment1 Intervention

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

Group II: ObservationalActive Control1 Intervention

Normative data development of performance on vestibular measures following mTBI

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Vestibular Hypofunction include vestibular rehabilitation therapy (VRT), which involves specific exercises designed to promote central nervous system compensation for inner ear deficits. These exercises typically focus on improving gaze stability, balance, and vertigo symptoms through habituation, adaptation, and substitution techniques. The mechanisms of action involve retraining the brain to use alternative sensory inputs and to better integrate vestibular information. This is crucial for patients as it helps reduce dizziness, improve balance, and enhance overall functional ability. Remote monitoring systems like MINDGAPS can track progress in real-time, providing valuable feedback and allowing for adjustments in therapy to optimize outcomes.