Cogmed for Working Memory After TBI

NCT02305212 | Completed

• 1 other identifier: 786-13 Cog
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Traumatic Brain Injury

Keywords

Working Memory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

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

Study Arms (2)

Cogmed

EXPERIMENTAL

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

Wait list

NO INTERVENTION

Interventions

Cogmed BEHAVIORAL

Cogmed

Eligibility Criteria

• Age: 9 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• History of Traumatic Brain Injury

You may not qualify if:

• Diagnosis of other neurological conditions

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (2)

Childrens Specialized Hosptial

Mountainside, New Jersey, 07092, United States

Location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Nancy Chiaravalloti, Ph.D.

  Kessler Fondation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 2, 2014
• Study Start: December 1, 2013
• Primary Completion: June 2, 2016
• Study Completion: June 2, 2016
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

US (2)