What side effects are associated with this type of intervention?

Vestibular rehabilitation therapy (VRT), which includes targeted rehabilitation exercises, is generally well-tolerated but can have some side effects. Common side effects include temporary dizziness, nausea, and imbalance, which may occur as the body adjusts to the exercises. These symptoms are usually mild and decrease over time as the patient progresses with the therapy. In rare cases, patients may experience headaches or increased anxiety. It is important for patients to communicate any adverse effects to their healthcare provider to adjust the treatment plan accordingly.

What prior FDA approvals exist?

The FDA has not specifically approved targeted rehabilitation exercises for vestibular disorders, but vestibular rehabilitation therapy (VRT) is a widely accepted non-pharmacological treatment. VRT involves specific exercises designed to improve balance and reduce dizziness-related symptoms. Pharmacological treatments for vestibular disorders that have FDA approval include meclizine and diazepam, which are used to manage symptoms such as vertigo and nausea. These treatments aim to alleviate symptoms rather than directly improve vestibular function.

What other types of research exist?

Promising novel alternatives to Targeted Rehabilitation Exercises for vestibular disorder patients include: 1) Virtual Reality (VR) therapy, which uses immersive environments to improve balance and spatial orientation; 2) Vestibular implants, which are devices surgically implanted to stimulate the vestibular nerve and restore function; 3) Pharmacological treatments targeting specific pathways involved in vestibular dysfunction; and 4) Non-invasive brain stimulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) to enhance neuroplasticity and vestibular compensation.

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Vestibular Treatment for Concussion

N/A

Waitlist Available

Led By Anthony P Kontos, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

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

Must have

Reported signs of mTBI including: loss of consciousness, amnesia, disorientation, confusion, dizziness, imbalance, memory problems, vomiting

18-50 years of age

Must not have

History of vestibular disorder prior to current mTBI (benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction)

Benign Paroxysmal Positional Vertigo (BPPV) resulting from vestibular hypofunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment, 2-week, 4-week, 3-month study visits

Awards & highlights

Summary

This trial tests different exercise routines to help people with mild brain injuries who have balance and dizziness issues. The goal is to find the best exercise plan to speed up recovery and improve outcomes. Participants will do these exercises at home and visit the clinic regularly for progress checks.

Who is the study for?

This trial is for individuals aged 18-50 who have had a sports-related mild traumatic brain injury (mTBI) or concussion within the last 8 days to 1 year. They must experience certain symptoms like dizziness, confusion, or balance issues but can't have had vestibular disorders before the mTBI or be currently pregnant.

What is being tested?

The study tests targeted rehabilitation exercises (T-REV) at different intensities and frequencies for treating vestibular symptoms after an mTBI. Participants will do these exercises daily at home and attend weekly clinic visits to adjust their program.

What are the potential side effects?

While not explicitly stated, potential side effects may include increased dizziness, fatigue from exercise, headaches, or discomfort due to the intensity of rehabilitation activities.

Eligibility Criteria

Inclusion Criteria

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

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I have experienced symptoms like confusion, dizziness, or memory problems.

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I am between 18 and 50 years old.

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My vision is normal or corrected to normal.

Exclusion Criteria

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

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I had a balance disorder before my recent mild brain injury.

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I have dizziness due to inner ear issues.

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I have a history of a neurological disorder.

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My recent mild brain injury occurred less than a month ago or over six months ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment, 2-week, 4-week, 3-month study visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment, 2-week, 4-week, 3-month study visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment, 2-week, 4-week, 3-month study visits for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dizziness Handicap Inventory (DHI)

Secondary study objectives

Behavioral Symptom Inventory-18 (BSI-18)

Dizziness Numerical Rating Scale (Dizziness NRS)

Functional Gait Assessment (FGA)

+12 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Low Intensity/Low FrequencyExperimental Treatment1 Intervention

Participants will be assigned T-REV with low intensity (30% of perceived effort) and low frequency (exercises performed 1x/day)

Group II: Low Intensity/ High FrequencyExperimental Treatment1 Intervention

Participants will be assigned T-REV with low intensity (30% of perceived effort) and high frequency (exercises performed 2x/day)

Group III: High Intensity/Low FrequencyExperimental Treatment1 Intervention

Participants will be assigned T-REV with high intensity (70% of perceived effort) and low frequency (exercises performed 1x/day)

Group IV: High Intensity/High FrequencyExperimental Treatment1 Intervention

Participants will be assigned T-REV with high intensity (70% of perceived effort) and high frequency (exercises performed 2x/day)

0 / 7Eligibility criteria met

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

The most common treatments for vestibular disorders include targeted rehabilitation exercises, which aim to improve vestibular function through specific exercises. These exercises work by promoting neuroplasticity, which helps the brain to adapt and compensate for vestibular deficits. They often involve balance training, gaze stabilization exercises, and habituation exercises that reduce dizziness by gradually exposing patients to the movements that trigger their symptoms. This approach is crucial for patients as it directly addresses the underlying dysfunctions in the vestibular system, leading to improved balance, reduced dizziness, and enhanced overall quality of life.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

891 Previous Clinical Trials

332,357 Total Patients Enrolled

University of PittsburghLead Sponsor

1,762 Previous Clinical Trials

16,347,882 Total Patients Enrolled

3 Trials studying Vestibular Disorder

130 Patients Enrolled for Vestibular Disorder

Anthony P Kontos, PhDPrincipal InvestigatorUniversity of Pittsburgh

4 Previous Clinical Trials

166 Total Patients Enrolled

1 Trials studying Vestibular Disorder

50 Patients Enrolled for Vestibular Disorder

Media Library

T-REV Clinical Trial Eligibility Overview. Trial Name: NCT03600324 — N/A

Vestibular Disorder Research Study Groups: High Intensity/High Frequency, High Intensity/Low Frequency, Low Intensity/Low Frequency, Low Intensity/ High Frequency

Vestibular Disorder Clinical Trial 2023: T-REV Highlights & Side Effects. Trial Name: NCT03600324 — N/A

T-REV 2023 Treatment Timeline for Medical Study. Trial Name: NCT03600324 — N/A

~22 spots leftby Sep 2025

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