Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI) (CRbTBI)
Primary Purpose
Traumatic Brain Injury, Cognitive Symptoms
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Intervention
Educational intervention
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Rehabilitation Outcome, Cognitive treatment, TBI
Eligibility Criteria
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
Sites / Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Cognitive intervention
Educational intervention
Outcomes
Primary Outcome Measures
Cognitive functioning
Scaled Score on the standardized neuropsychological testing
Secondary Outcome Measures
Daily functioning
Total Score on the daily functioning measure
Full Information
NCT ID
NCT01138020
First Posted
June 3, 2010
Last Updated
October 18, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01138020
Brief Title
Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)
Acronym
CRbTBI
Official Title
Cognitive Rehabilitation of Blast-induced Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2011 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Cognitive Symptoms
Keywords
Rehabilitation Outcome, Cognitive treatment, TBI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Cognitive intervention
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Educational intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Intervention
Intervention Description
Cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention
Intervention Description
Educational intervention is geared at personal management of TBI-related symptoms.
Primary Outcome Measure Information:
Title
Cognitive functioning
Description
Scaled Score on the standardized neuropsychological testing
Time Frame
Ten weeks
Secondary Outcome Measure Information:
Title
Daily functioning
Description
Total Score on the daily functioning measure
Time Frame
Ten weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yelena Bogdanova, PhD PhD
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-4817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22350691
Citation
Bogdanova Y, Verfaellie M. Cognitive sequelae of blast-induced traumatic brain injury: recovery and rehabilitation. Neuropsychol Rev. 2012 Mar;22(1):4-20. doi: 10.1007/s11065-012-9192-3. Epub 2012 Feb 17.
Results Reference
background
Learn more about this trial
Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)
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