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Cognitive Enhancement Techniques for Concussion (VoCET-mTBI Trial)

N/A
Waitlist Available
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
Must not have
History of moderate, severe, or penetrating TBI as defined by DOD/VA guidelines during their lifetime
History of neurological diseases other than mild TBI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a head injury that affected my brain function.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a moderate to severe brain injury in my life.
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I have a history of neurological diseases, but not beyond mild traumatic brain injury.
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I have difficulty making decisions due to my health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 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 cognitive impairment
Secondary study objectives
Change in healthcare utilization
Change in level of occupational performance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

The Defense and Veterans Brain Injury CenterLead Sponsor
20 Previous Clinical Trials
2,719 Total Patients Enrolled
The University of Texas at DallasOTHER
64 Previous Clinical Trials
106,682 Total Patients Enrolled

Media Library

Strategic Memory Advanced Reasoning Training Clinical Trial Eligibility Overview. Trial Name: NCT04245124 — N/A
Concussion Research Study Groups: SMART INTERVENTION, TCR
Concussion Clinical Trial 2023: Strategic Memory Advanced Reasoning Training Highlights & Side Effects. Trial Name: NCT04245124 — N/A
Strategic Memory Advanced Reasoning Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04245124 — N/A
~34 spots leftby Dec 2025
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