Cogmed for Working Memory After TBI

Traumatic Brain Injury Clinical Trial

— Cogmed  

Official title:

Applying Cogmed to Improve Working Memory Abilities After Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305212
• Other study ID #: 786-13 Cog
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: June 30, 2017
• Start date: December 2013
• Est. completion date: June 2, 2016

Study information

• Verified date: June 2017
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2, 2016
• Est. primary completion date: June 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 59 Years

Eligibility

Inclusion Criteria:

• History of Traumatic Brain Injury

Exclusion Criteria:

• Diagnosis of other neurological conditions

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Behavioral:
• Cogmed

Locations

Country	Name	City	State
United States	Childrens Specialized Hosptial	Mountainside	New Jersey
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in scores on standardized tests of working memory	Measured via standardized neuropsychological tests (i.e. paper and pencil testing)	Three points in time: Baseline assessment, Week 7 and Week 13
Secondary	Change in scores on self report measures of emotional functioning, assessed via questionnaire		Three points in time: Baseline assessment, Week 7 and Week 13
Secondary	Change in scores on self report measures of memory functioning, assessed via questionniare		Three points in time: Baseline assessment, Week 7 and Week 13
Secondary	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