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Cognitive Enhancement Techniques for Concussion (VoCET-mTBI Trial)
N/A
Recruiting
Research Sponsored by The Defense and Veterans Brain Injury Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have experienced an external force to the head resulting in physiological dysfunction of the brain with specific acute symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 months
Awards & highlights
VoCET-mTBI Trial Summary
This trial will test the feasibility of a new cognitive rehabilitation intervention, CogReHab, which is a combination of cognitive training, metacognitive strategy instruction, and task-oriented practice delivered through a mobile app. The investigators hypothesize that the CogReHab intervention will 1) be feasible to deliver in a military treatment facility (MTF), 2) be acceptable to service members, and 3) result in better performance on measures of cognition, activities of daily living, and community integration compared to usual care at 3 and 6 months after baseline.
Who is the study for?
This trial is for active duty military personnel, aged 18 or older, who have had a mild traumatic brain injury (mTBI) more than 3 months ago. They must be experiencing ongoing symptoms compared to normal levels. Those with recent TBI, suicidal thoughts, impaired decision-making, other neurological diseases, severe TBI history or current substance abuse cannot participate.Check my eligibility
What is being tested?
The study tests two cognitive rehabilitation methods for mTBI: Strategic Memory Advanced Reasoning Training and Traditional Cognitive Rehabilitation. It aims to see which method better helps service members recover cognitive functions and improve daily living activities after an injury.See study design
What are the potential side effects?
Since the interventions are non-medical cognitive training programs rather than drugs or medical procedures, they typically do not have physical side effects. However, participants may experience mental fatigue or frustration during the exercises.
VoCET-mTBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a head injury that affected my brain function.
VoCET-mTBI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cognitive impairment
Secondary outcome measures
Change in healthcare utilization
Change in level of occupational performance
VoCET-mTBI Trial Design
2Treatment groups
Experimental Treatment
Group I: TCRExperimental Treatment1 Intervention
N= 81 60 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION
Group II: SMART INTERVENTIONExperimental Treatment1 Intervention
N= 81 20 HOURS THERAPY IMMEDIATE POST TREATMENT EVALUATION 3 MONTH POST TREATMENT EVALUATION
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Who is running the clinical trial?
The Defense and Veterans Brain Injury CenterLead Sponsor
19 Previous Clinical Trials
2,559 Total Patients Enrolled
The University of Texas at DallasOTHER
58 Previous Clinical Trials
106,073 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently thinking about hurting yourself or someone else.You currently have a problem with using drugs or alcohol based on what you tell the doctor.I am 18 years old or older.I have had a moderate to severe brain injury in my life.I have a history of neurological diseases, but not beyond mild traumatic brain injury.I had a mild traumatic brain injury more than 3 months ago.I had a traumatic brain injury within the last 3 months.I have had a head injury that affected my brain function.I have difficulty making decisions due to my health condition.I have long-lasting symptoms after a concussion that are worse than what's considered normal.
Research Study Groups:
This trial has the following groups:- Group 1: SMART INTERVENTION
- Group 2: TCR
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.
How many subjects are being evaluated in this investigation?
"Indeed, according to the information available on clinicaltrials.gov, this research project is presently seeking participants. It was initially posted on February 1st 2021 and recently edited on the same date; 162 individuals are required from a single site."
Answered by AI
Are there any opportunities currently to enroll in this clinical experiment?
"Confirmed. Clinicaltrials.gov demonstrates that this clinical trial, which first appeared on February 1st 2021, is actively recruiting participants. 162 people needs to be recruited from a single medical facility."
Answered by AI
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