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Cogmed for Working Memory After TBI (Cogmed)

Primary Purpose

Traumatic Brain Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cogmed

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Working Memory

Eligibility Criteria

9 Years - 59 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

History of Traumatic Brain Injury

Exclusion Criteria:

Diagnosis of other neurological conditions

Sites / Locations

Childrens Specialized Hosptial
Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cogmed

Wait list

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in scores on standardized tests of working memory

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

Secondary Outcome Measures

Change in scores on self report measures of emotional functioning, assessed via questionnaire

Change in scores on self report measures of memory functioning, assessed via questionniare

Change in scores on self report measures of quality of life, assessed via questionnaire

Full Information

NCT ID

NCT02305212

First Posted

December 19, 2013

Last Updated

June 30, 2017

Sponsor

Kessler Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02305212

Brief Title

Cogmed for Working Memory After TBI

Acronym

Cogmed

Official Title

Applying Cogmed to Improve Working Memory Abilities After Traumatic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

June 2, 2016 (Actual)

Study Completion Date

June 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kessler Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

Keywords

Working Memory

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cogmed

Arm Type

Experimental

Arm Description

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.

Arm Title

Wait list

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Cogmed

Primary Outcome Measure Information:

Title

Change in scores on standardized tests of working memory

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of Traumatic Brain Injury Exclusion Criteria: Diagnosis of other neurological conditions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy Chiaravalloti, Ph.D.

Organizational Affiliation

Kessler Fondation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Childrens Specialized Hosptial

City

Mountainside

State/Province

New Jersey

ZIP/Postal Code

07092

Country

United States

Facility Name

Kessler Foundation

City

West Orange

State/Province

New Jersey

ZIP/Postal Code

07052

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Cogmed for Working Memory After TBI

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