Cogmed for Working Memory After TBI

NCT ID: NCT02305212

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cogmed

Intervention Type BEHAVIORAL

Wait list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cogmed

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* History of Traumatic Brain Injury

Exclusion Criteria

* Diagnosis of other neurological conditions
Minimum Eligible Age

9 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Nancy Chiaravalloti

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nancy Chiaravalloti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kessler Fondation

Locations

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Childrens Specialized Hosptial

Mountainside, New Jersey, United States

Site Status

Kessler Foundation

West Orange, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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786-13 Cog

Identifier Type: -

Identifier Source: org_study_id

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