Cognitive Rehabilitation and Brain Activity of Attention Control in TBI

NCT ID: NCT02589509

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2018-10-31

Brief Summary

The purpose of this study is to test an innovative combination of direct-attention training and metacognitive training in the treatment of attention impairments in Veterans with moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems. Enrolled participants will be randomized to receive either the direct-attention training or metacognitive training first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks and a post-treatment 4 weeks later. In addition to the rehabilitation treatments, participants will also perform measures of complex functional activities (e.g., independent activities of daily living or IADLs) and neurocognitive tests of attention-control functions. Participants will also perform an attentional task that probes the function of three different attentional systems while brain wave activity (i.e., electroencephalography or EEG) is being recorded in order to assess changes in brain function that may be improved by the rehabilitation approach. Planned enrollment will be 36 Veterans.

Detailed Description

Attention impairment is ubiquitous in TBI survivors. This is a devastating impairment because attention is the backbone of cognitive systems. Attention is requisite for other cognitive processes that are vital to everyday functioning such as memory, problem solving, language skills, and the cognitive control of behavior. Studies of attention training have shown improved attention on laboratory measures, but limited translation to real-world tasks. Notably, these previously-tested rehabilitation approaches have not included training in the very cognitive processes needed for translation of training to everyday tasks which include internal verbalization and self-monitoring, also called metacognitive strategies. One training method for metacognitive strategies has shown promise, but is lacking in basic attention training. Rehabilitation specialists have recently argued for a rehabilitation approach wherein both basic foundational attention and metacognitive strategies should be synergistically combined. Consequently, the investigators will test an innovative combination of direct-attention training and metacognitive training for which the other compensates disadvantages of each. Because of the promise of each type of training separately, and the potential additive effects of the combination, it is critical to test this combined attention and metacognitive training in Veteran survivors of chronic moderate-to-severe traumatic brain injury (TBI). The investigators will address the following two specific aims: the investigators propose to conduct a pilot study to examine cognitive rehabilitation therapy (CRT) effects in a group of Veterans with chronic moderate to severe TBI (m/sTBI), focused on remediating attention-control impairments using both direct-attention and metacognitive-strategy training approaches in a AB/BA crossover design with 1-month follow-up to address the following two specific aims: 1) Test treatment response to combined direct-attention and metacognitive-strategy training in Veterans with chronic m/sTBI; and 2) identify mechanisms and biomarkers of rehabilitation-related neuroplasticity. Under the first aim the investigators will test for effects of combined direct-attention and metacognitive-strategy training on measures of complex functional activities and neurocognitive tests of attention-control functions. Under the second aim, the investigators will test effects of the their CRT approach on behavioral and brain activity while participants perform a well-validated attentional task that probes the function of three dissociable attentional systems. The approach is innovative because it combines a theoretically motivated and novel approach to address a significant source of disability in Veteran survivors of TBI. The proposed research is significant because findings will form the foundation for a larger-scale trial to enable us to determine the durability of gains and the functional impact of treatment on Veteran's real world activities and to more positively shape healthcare for our Veterans who are suffering from TBI. Outcome measures will include standardized tests of neurocognitive functioning such as attention and other cognitive skills, measures of self care, ability to live independently, social role participation, life satisfaction, TBI-related quality of life, mood/anxiety, and attention-related scalp-recorded brain event-related potentials (ERPs, derived from electroencephalography).

Conditions

Brain Injuries, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Direct-Metacognitive

Direct attention training followed by metacognitive strategy training

Group Type: EXPERIMENTAL

Direct-attention training using web-based BrainHQ

Intervention Type: BEHAVIORAL

BrainHQ (by Posit Science Corp.) computerized attention training using the following modules: "Divided attention," "Target tracker," "Double Decision," "Mixed Signals," and "Freeze Frame."

Goal Management Training (GMT)

Intervention Type: BEHAVIORAL

A compensatory metacognitive strategy-based intervention program that teaches strategies for improving attentional control and problem solving.

Metacognitive-Direct

Metacognitive strategy training followed by direct-attention training

Group Type: EXPERIMENTAL

Direct-attention training using web-based BrainHQ

Intervention Type: BEHAVIORAL

BrainHQ (by Posit Science Corp.) computerized attention training using the following modules: "Divided attention," "Target tracker," "Double Decision," "Mixed Signals," and "Freeze Frame."

Goal Management Training (GMT)

Intervention Type: BEHAVIORAL

A compensatory metacognitive strategy-based intervention program that teaches strategies for improving attentional control and problem solving.

Interventions

Direct-attention training using web-based BrainHQ

BrainHQ (by Posit Science Corp.) computerized attention training using the following modules: "Divided attention," "Target tracker," "Double Decision," "Mixed Signals," and "Freeze Frame."

Intervention Type: BEHAVIORAL

Goal Management Training (GMT)

A compensatory metacognitive strategy-based intervention program that teaches strategies for improving attentional control and problem solving.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• OEF/OIF/OND Veterans with moderate or severe TBI as described by DOD/VA common definition.
• Self-report of attentional problems, confirmed with psychometric testing.
• Ruff 2 & 7 selective attention task score <= 1.5 standard deviations from demographically-matched norms.
• Able to participate in study at 12-60 months post injury without contraindications.
• Age 21-55 years.
• Willingness to be randomized and to participate in treatment procedures.
• Capacity to visit the laboratory for repeated treatment and testing sessions.
• Access to internet-enabled home computer.
• English as Native language.
• Adequate reading comprehension to allow completion of study-related questionnaires.
• Reliable digit span (RDS) score > 7.

Exclusion Criteria

• Pre-existing neurological disorder associated with cerebral dysfunction (e.g., stroke, history of epilepsy or chronic seizure disorder).
• Current alcohol or drug use/dependence.
• Pre-existing severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or history of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
• Current suicidal or homicidal ideation.
• Reported involvement in current litigation.
• Reported history of pre-injury learning disability.
• Not competent to provide written informed consent (i.e., not able to demonstrate understanding or expectations of study and potential risks of participation).
• Does not fully understand the nature of the study and requirements of participation.
• Does not understand task instructions.
• Validity testing score on RDS <= 7.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William M Perlstein, PhD

Role: PRINCIPAL_INVESTIGATOR

North Florida/South Georgia Veterans Health System, Gainesville, FL

Locations

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States

Countries

United States

Other Identifiers

I21RX001920-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N1920-P

Identifier Type: -

Identifier Source: org_study_id