Cognitive Rehabilitation of Blast Traumatic Brain Injury (TBI)

NCT ID: NCT01138020

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-01

Study Completion Date

2027-10-31

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury Cognitive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm 1

Cognitive intervention

Group Type EXPERIMENTAL

Cognitive Intervention

Intervention Type BEHAVIORAL

Cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function

Arm 2

Educational intervention

Group Type ACTIVE_COMPARATOR

Educational intervention

Intervention Type BEHAVIORAL

Educational intervention is geared at personal management of TBI-related symptoms.

Interventions

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Cognitive Intervention

Cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function

Intervention Type BEHAVIORAL

Educational intervention

Educational intervention is geared at personal management of TBI-related symptoms.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yelena Bogdanova, PhD PhD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

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VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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D6996-W

Identifier Type: -

Identifier Source: org_study_id

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