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Behavioral Intervention

Cognitive Rehabilitation for Traumatic Brain Injury (CRbTBI Trial)

N/A
Waitlist Available
Led By Yelena Bogdanova, PhD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Loss of consciousness (LOC) of 30 min or less
Age: 21-50
Must not have
Evidence of penetrating head injury
Hearing or vision impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ten weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether a structured rehabilitation program can help improve cognitive function and quality of life for people with bTBI.

Who is the study for?
This trial is for active-duty personnel or Veterans aged 21-50 who served in OEF/OIF and have mild traumatic brain injury from a blast with loss of consciousness under 30 minutes. It's not for those with penetrating head injuries, previous neurological diagnoses, psychotic disorders before the blast, or significant hearing/vision problems.
What is being tested?
The study tests how well a structured cognitive rehabilitation program can improve thinking skills and life quality in people with brain injuries caused by blasts. Participants will receive either cognitive interventions or educational sessions to aid their recovery.
What are the potential side effects?
Since this trial involves non-medical interventions like education and cognitive exercises, there are no typical drug side effects; however, participants may experience fatigue or frustration during challenging tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have lost consciousness for 30 minutes or less.
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I am between 21 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a penetrating injury to my head.
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I have a hearing or vision problem.
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I have a history of neurological conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ten weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and ten weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cognitive functioning
Secondary study objectives
Daily functioning

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
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
Cognitive intervention
Group II: Arm 2Active Control1 Intervention
Educational intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Intervention
2017
N/A
~1120

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,520 Total Patients Enrolled
Yelena Bogdanova, PhD PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Cognitive Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT01138020 — N/A
Traumatic Brain Injury Research Study Groups: Arm 1, Arm 2
Traumatic Brain Injury Clinical Trial 2023: Cognitive Intervention Highlights & Side Effects. Trial Name: NCT01138020 — N/A
Cognitive Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01138020 — N/A
~9 spots leftby Oct 2026
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