Cogmed for Working Memory After TBI (Cogmed)

June 30, 2017 updated by: Nancy Chiaravalloti, Kessler Foundation

Applying Cogmed to Improve Working Memory Abilities After Traumatic Brain Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Mountainside, New Jersey, United States, 07092
        • Childrens Specialized Hosptial
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 59 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of Traumatic Brain Injury

Exclusion Criteria:

  • Diagnosis of other neurological conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Wait list
Experimental: Cogmed
Cogmed is a cognitive rehabilitation protocol designed to improve working memory. The Cogmed sessions are on a computer at home for 30-40 min per day, 5 days per week for 5 weeks.
Behavioral: Cogmed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Three points in time: Baseline assessment, Week 7 and Week 13

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Investigators

  • Principal Investigator: Nancy Chiaravalloti, Ph.D., Kessler Fondation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

June 2, 2016

Study Completion (Actual)

June 2, 2016

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 786-13 Cog

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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