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Neural Bases of Cognitive Rehabilitation for Brain Injury

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VA Office of Research and Development

Status

Completed

Conditions

Brain Injury

Treatments

Behavioral: Brain Health Education
Behavioral: Goal-oriented attentional self-regulation

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01120756
B7467-I

Details and patient eligibility

About

Some of the most common and disabling consequences of brain injury are deficits in cognition, such as difficulty with sustained attention, memory, organization, and goal management. The long-term goal of this research program is to develop and test novel neuroscience-based cognitive interventions for improving attentional regulation and related "executive function" brain processes involved in goal-directed behavior.

Full description

Brain injury often results in a disruption of attention regulation processes, which reduces the efficiency and effectiveness of cognitive functions including learning, memory, problem-solving and goal management, leading to significant functional disability. More intervention options are needed.

We set out to test different possible interventions. Individuals with traumatic brain injury (TBI) and chronic executive control dysfunction participate in interventions, with pre- and post-intervention measurements of cognitive functioning. Training in Goal-oriented attentional self-regulation (GOALS) was administered in comparison to Brain Health Education (EDU).

GOALS is designed to train attention regulation skills along with meta-cognitive strategies for goal management, with a emphasis on application to participant-selected projects. This is a group-based intervention.

Brain Health Education is designed to increase knowledge and understanding of key factors that affect brain functioning. This is a group-based intervention matched to the GOALS intervention.

Enrollment

35 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients with a history of TBI (reported plausible mechanism of head injury, loss of consciousness with some period of post-traumatic alteration in cognition) who are > 6 months post-injury will be screened for evidence of mild-moderate residual dysfunction in executive control functions based on corroborated reports of real-world difficulties (Mayo-Portland Adaptability Inventory).

Exclusion criteria

  • Severely apathetic/abulic
  • aphasic
  • or other reasons for patients being unable or unwilling to participate with the training tasks
  • severe cognitive dysfunction
  • history of neurodevelopmental abnormalities
  • ongoing illicit drug or alcohol abuse (AUDIT>8)
  • severe depression as measured by Beck Depression Inventory (>29)
  • severe PTSD precluding participation in research activities (such as group training or MRI scanning)
  • There will be no restriction in regard to gender, race and socioeconomic status.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

35 participants in 2 patient groups

Goal-oriented attentional self-regulation training
Experimental group
Description:
Goal-oriented attentional self-regulation training (GOALS).
Treatment:
Behavioral: Goal-oriented attentional self-regulation
Brain Health Education
Active Comparator group
Description:
Brain Health Education (EDU)
Treatment:
Behavioral: Brain Health Education

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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