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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ten weeks
Awards & highlights
CRbTBI Trial 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.Check my eligibility
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.See study design
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.
CRbTBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have lost consciousness for 30 minutes or less.
Select...
I am between 21 and 50 years old.
CRbTBI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ten weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ten weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cognitive functioning
Secondary outcome measures
Daily functioning
CRbTBI 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
2016
N/A
~1120
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,526 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a penetrating injury to my head.I have lost consciousness for 30 minutes or less.I have a hearing or vision problem.Military personnel or veterans who were exposed to explosions during Operation Enduring Freedom (OEF) or Operation Iraqi Freedom (OIF).I am between 21 and 50 years old.I have a history of neurological conditions.You had a mental illness like schizophrenia before the blast.You have a mild traumatic brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
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.
Is the age restriction of this clinical trial limited to those above 25 years old?
"As outlined in the study's requirements, participants must fall between 21 and 50 years of age."
Answered by AI
To which population is participation in this trial open?
"This research study is looking to enrol 77 individuals aged between 21 and 50 with existing wounds who have been exposed to blasts in either Operation Enduring Freedom or Operation Iraqi Freedom. Additionally, participants must meet the criterion of mild traumatic brain injury (TBI) associated with a maximum loss of consciousness (LOC) lasting 30 minutes or less."
Answered by AI
Are there any vacancies left open for prospective participants in this clinical trial?
"The records on clinicaltrials.gov show that this medical trial, which was first posted in March of 2011, has stopped searching for new patients at the present moment. Despite that, there are currently 913 other studies actively recruiting participants."
Answered by AI
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