Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI) (CRbTBI)

VA Office of Research and Development

Status: Active, not recruiting

Conditions: Cognitive Symptoms; Traumatic Brain Injury

Treatments: Behavioral: Educational intervention; Behavioral: Cognitive Intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01138020

D6996-W

Details and patient eligibility

About

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).

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 2 patient groups

Arm 1

Experimental group

Description:

Cognitive intervention

Treatment:

Behavioral: Cognitive Intervention

Arm 2

Active Comparator group

Description:

Educational intervention

Treatment:

Behavioral: Educational intervention