- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01138020
Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI) (CRbTBI)
October 18, 2023 updated by: VA Office of Research and Development
Cognitive Rehabilitation of Blast-induced Traumatic Brain Injury
The purpose of this study is to investigate the efficacy of a structured rehabilitation program on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The most common impairments following blast-induced traumatic brain injury (bTBI) are cognitive deficits in the domain of executive functioning, learning and memory, and functional and psychosocial disabilities that are closely related to these cognitive deficits.
There are no treatment protocols available to address the multiple cognitive impairments in bTBI, but cognitive rehabilitation has proven efficacious in the treatment of non-blast TBI.
The cognitive training modules the investigators plan to evaluate have improved organization and memory function in patients with non-blast TBI, but it is unknown whether their efficacy exceeds that of programs that focus only on education and support.
This study is a between group comparison of a cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function, and an active control group receiving educational intervention geared at personal management of TBI-related symptoms.
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130-4817
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) active-duty personnel or Veterans exposed to blast
- Meets criteria for mild TBI
- loss of consciousness (LOC) of 30 min or less
- Age: 21- 50
Exclusion Criteria:
- Evidence of penetrating head injury
- History of previous neurological diagnosis
- History of previous psychotic disorder prior to the blast exposure
- Hearing or vision impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Cognitive intervention
|
Cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function
|
Active Comparator: Arm 2
Educational intervention
|
Educational intervention is geared at personal management of TBI-related symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive functioning
Time Frame: Ten weeks
|
Scaled Score on the standardized neuropsychological testing
|
Ten weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily functioning
Time Frame: Ten weeks
|
Total Score on the daily functioning measure
|
Ten weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yelena Bogdanova, PhD PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2011
Primary Completion (Estimated)
October 31, 2025
Study Completion (Estimated)
October 31, 2026
Study Registration Dates
First Submitted
June 3, 2010
First Submitted That Met QC Criteria
June 4, 2010
First Posted (Estimated)
June 7, 2010
Study Record Updates
Last Update Posted (Actual)
October 19, 2023
Last Update Submitted That Met QC Criteria
October 18, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D6996-W
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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