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Clinical Trials/NCT02305212
NCT02305212
Completed
Not Applicable

Applying Cogmed to Improve Working Memory Abilities After Traumatic Brain Injury

Kessler Foundation2 sites in 1 country12 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Kessler Foundation
Enrollment
12
Locations
2
Primary Endpoint
Change in scores on standardized tests of working memory
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study will examine a cognitive rehabilitation protocol targeted at working memory deficits for adults and children with Traumatic Brain Injury (TBI). In this randomized clinical trial, the efficacy of Cogmed, a cognitive rehabilitation protocol designed to improve working memory, will be examined in children with TBI. Neuropsychological and daily life functioning will be measured. Participants will be children (N=20) and adults (N=20) with a documented history of TBI. Participants will be randomized to a treatment group or a wait list control group. The Experimental Group will receive the Cogmed working memory training program 30-40 minutes per day, 5 days a week for 5 weeks for a total training time of approximately 15 hours. The Control Group will be a wait list control group that will cross over into treatment after the follow-up assessment. All subjects will undergo repeat assessments following completion of the working memory training protocol after the 7th week and again at 13 weeks to document changes in working memory performance.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
June 2, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Principal Investigator
Principal Investigator

Nancy Chiaravalloti

Director

Kessler Foundation

Eligibility Criteria

Inclusion Criteria

  • History of Traumatic Brain Injury

Exclusion Criteria

  • Diagnosis of other neurological conditions

Outcomes

Primary Outcomes

Change in scores on standardized tests of working memory

Time Frame: Three points in time: Baseline assessment, Week 7 and Week 13

Measured via standardized neuropsychological tests (i.e. paper and pencil testing)

Secondary Outcomes

  • Change in scores on self report measures of quality of life, assessed via questionnaire(Three points in time: Baseline assessment, Week 7 and Week 13)
  • Change in scores on self report measures of memory functioning, assessed via questionniare(Three points in time: Baseline assessment, Week 7 and Week 13)
  • Change in scores on self report measures of emotional functioning, assessed via questionnaire(Three points in time: Baseline assessment, Week 7 and Week 13)

Study Sites (2)

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