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Cognitive Rehabilitation and Brain Activity of Attention Control in TBI

NCT02589509 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-02-15

No results posted yet for this study

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.

Conditions

  • Brain Injuries, Traumatic

Interventions

BEHAVIORAL

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."

BEHAVIORAL

Goal Management Training (GMT)

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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • William M Perlstein, PhD · North Florida/South Georgia Veterans Health System, Gainesville, FL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02589509 on ClinicalTrials.gov