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OpenTrials
Completed

NCT Number: NCT02305212

Cogmed for Working Memory After TBI

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

9 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Specialized Hosptial, Mountainside, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of Traumatic Brain Injury

Exclusion criteria

  • Diagnosis of other neurological conditions

Treatment and study plan

Cogmed

Behavioral

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

Applying Cogmed to Improve Working Memory Abilities After Traumatic Brain Injury

Acronym: Cogmed

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2014
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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