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Brain Markers of Improvements in Cognitive Functioning

NCT03490110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-03-23

Study results available
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Summary

Some of the most common, persistent, and disabling consequences of traumatic brain injury affect an individual's ability to achieve personal goals. Interventions that strengthen abilities such as being able to concentrate, remember, stay calm and overcome challenges, could have far reaching benefits for Veterans. One challenge in rehabilitation is that response to training can be highly variable, and a better understanding of the neural bases for this variability could inform care. This pilot project will test the clinical behavioral effects of a cognitive skill training intervention and explore to what extent changes in markers of the brain's electrical activity (using the non-invasive technique of electroencephalograms, EEG) can explain differences in responses to skill training.

Conditions

  • TBI (Traumatic Brain Injury)
  • Brain Injuries
  • Stress
  • Attention Deficit
  • Executive Dysfunction

Interventions

BEHAVIORAL

State regulation skill training

Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total \~4.5 hours per week).

OTHER

Treatment-as-usual

Participants receive clinical care as usual over a matched time period.

Sponsors & Collaborators

  • VA Northern California Health Care System

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Anthony Chen, MD MA · VA Northern California Health Care System, Mather, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-03-01
Completion
2019-06-01

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 NCT03490110 on ClinicalTrials.gov