Clinical trial NCT01120756: Neural Bases of Cognitive Rehabilitation for Brain Injury
Official title: Neural Bases of Cognitive Rehabilitation for Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Keywords: executive dysfunction
brain injury
attention
rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, Berkeley
First posted: 2010-05-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions
timeFrame: Baseline, Within 2-3 weeks Post-intervention
Secondary outcomes:
measure: Functional Evaluations: Change From Baseline on the Goal Processing Scale
timeFrame: Baseline, 2-3 Weeks Post-intervention
Other outcomes:
Locations:
city: Martinez
country: United States
facility: Martinez Outpatient Clinic and Community Living Center, Martinez, CA
state: California
Study officials:
affiliation: Martinez Outpatient Clinic, Martinez, CA
name: Anthony Chen, MD MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Novakovic-Agopian T, Kornblith E, Abrams G, Burciaga-Rosales J, Loya F, D'Esposito M, Chen AJW. Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. J Neurotrauma. 2018 Dec 1;35(23):2784-2795. doi: 10.1089/neu.2017.5529. Epub 2018 Jul 23.