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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
MINDGAPS Trial Summary
This trial aims to create standards for measuring inner ear function and mental health, and test if the MINDGAPS system can help track recovery from inner ear issues after head injuries.
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.Check my eligibility
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.See study design
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.
MINDGAPS Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Computerized Dynamic Visual Acuity (cDVA)
Secondary outcome measures
Dizziness Handicap Inventory (DHI)
Functional Gait Assessment (FGA)
General Well Being Scale
+11 moreMINDGAPS 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
Find a Location
Who is running the clinical trial?
United States Naval Medical Center, San DiegoFED
102 Previous Clinical Trials
22,216 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
48 Previous Clinical Trials
6,276 Total Patients Enrolled
University of MontanaLead Sponsor
24 Previous Clinical Trials
3,074 Total Patients Enrolled
1 Trials studying Vestibular Hypofunction
36 Patients Enrolled for Vestibular Hypofunction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a spine disorder in my neck.I have been diagnosed with artery problems in my neck.I am legally able to make my own health decisions.I am getting physical therapy for balance or dizziness.I have been diagnosed with abnormal eye movements.I have had a stroke or have been diagnosed with a neurodegenerative disorder.I have had a brain tumor in the past.I can stand up on my own.I have had a serious head injury with loss of consciousness for over 30 minutes.
Research Study Groups:
This trial has the following groups:- Group 1: Rehab
- Group 2: Observational
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the uppermost capacity of participants taking part in this clinical investigation?
"Affirmative. Clinicaltrials.gov information confirms that this research study, initially posted on August 30th 2023, is actively recruiting participants. Approximately 500 individuals need to be enlisted from 2 distinct medical centres."
Answered by AI
Are there any slots available for potential participants of this experiment?
"Affirmative. According to the information furnished by clinicaltrials.gov, this investigation is actively seeking participants and was first made available on August 30th 2023 with a recent update taking place in early August of that same year. Five hundred individuals need to be enrolled from two different medical centres."
Answered by AI
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