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IVE Therapy vs Traditional Rehabilitation for Concussion (INVENT Trial)

N/A

Recruiting

Led By Michael C Schubert, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Service members with mTBI and civilian patients with vestibular hypofunction, both of which reports vestibular symptoms (i.e. dizziness, imbalance).

Be older than 18 years old

Must not have

Greater than or equal to 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly, up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing a new device that improves the vestibulo-ocular reflex against traditional vestibular rehabilitation in people with mild traumatic brain injury or vestibular hypofunction.

Who is the study for?

This trial is for active duty service members with mild traumatic brain injury (mTBI) and civilians who have vestibular hypofunction, experiencing symptoms like dizziness or imbalance. Participants must be at least 18 years old.

What is being tested?

The study compares traditional Vestibular Rehabilitation Therapy (VPT) to a new device called Incremental Velocity Error (IVE), which aims to enhance the performance of the vestibulo-ocular reflex that helps with balance and eye movements.

What are the potential side effects?

Since this trial involves physical therapy techniques and a non-invasive device, side effects may include temporary increased dizziness or nausea during exercises, fatigue, headache, or discomfort from using the IVE equipment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a mild traumatic brain injury or vestibular hypofunction and experience dizziness or imbalance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly, up to 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in vestibulo-ocular reflex (VOR) Gain

Secondary study objectives

5 min Rate of Perceived Exertion for the Patrol Exertion Multitask Test (PEMT)

Baseline oculomotor function assessed with Videonystagmography/Electronystagmography (VNG/ENG)

Baseline vestibular function assessed with Rotary Chair

+25 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: IVE/VPT 3 week CrossoverExperimental Treatment2 Interventions

Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training will not start until the washout period.

Group II: IVE/VPT 6 week CrossoverActive Control2 Interventions

Subjects will randomly be placed in one of two groups (IVE or VPT) involving daily exercise for 5 weeks, 6 weeks washout, and then crossover into the other group for a final 5 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout each of the 5 weeks epochs of training.

Group III: IVE/VPT 3 week crossoverActive Control2 Interventions

Subjects will randomly be placed in one of two groups (IVE or VPT) involving every other day exercise for 3 weeks, 3 weeks washout, and then crossover into the other group for a final 3 weeks. The Incremental Velocity Error (IVE) group uses a device worn on the head that delivers a moving target during head motion; while Traditional Vestibular Rehabilitation (VPT) uses the traditional eye and head turning rehabilitation exercises. Gait and balance training offered throughout the 3 weeks of exercise.

0 / 2Eligibility criteria met