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Vestibular Treatment for Concussion

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment, 2-week, 4-week, 3-month study visits
Awards & highlights

Study Summary

This trial will test the effectiveness of targeted rehabilitation exercises for vestibular symptoms and impairments in civilians with mild traumatic brain injury.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dizziness Handicap Inventory (DHI)
Secondary outcome measures
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)

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
865 Previous Clinical Trials
327,574 Total Patients Enrolled
University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,342,821 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Randomized Controlled Trial for Vestibular Treatment in Concussion
Anthony P. Kontos, Ph.D. 2020. "Randomized Controlled Trial for Vestibular Treatment in Concussion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03600324.
All > Concussion
~2 spots leftby Jun 2024
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