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NCT01138020 Clinical Trial

Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)

Traumatic Brain Injury Clinical Trial

— CRbTBI  

Official title:
Cognitive Rehabilitation of Blast-induced Traumatic Brain Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01138020
Other study ID # D6996-W
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2011
Est. completion date October 31, 2026

Study information
Verified date October 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 77
Est. completion date October 31, 2026
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Cognitive Intervention
Cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function
• Educational intervention
Educational intervention is geared at personal management of TBI-related symptoms.

Locations
Country Name City State
United States VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cognitive functioning Scaled Score on the standardized neuropsychological testing Ten weeks
Secondary Daily functioning Total Score on the daily functioning measure Ten weeks
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