Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)

Not Applicable

Active, not recruiting

• Conditions: Traumatic Brain Injury; Cognitive Symptoms
• Interventions: Behavioral: Cognitive Intervention; Behavioral: Educational intervention

• Registration Number: NCT01138020
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Study Start: 2011-03-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2025-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 77

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Cognitive Intervention	Cognitive intervention
Arm 2	Educational intervention	Educational intervention

Primary Outcome Measures

Name	Time	Method
Cognitive functioning	Ten weeks	Scaled Score on the standardized neuropsychological testing

Secondary Outcome Measures

Name	Time	Method
Daily functioning	Ten weeks	Total Score on the daily functioning measure

Trial Locations

Locations (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States