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Traumatic Brain InjuryCogmedNCT02305212

Cogmed for Working Memory After TBI

A study testing Cogmed in people with Traumatic Brain Injury, run by Kessler Foundation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 9 to 59 years
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Cogmed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
Dec 2013to 2 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 59 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • History of Traumatic Brain Injury

Who cannot join

  • Diagnosis of other neurological conditions

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Childrens Specialized Hosptial

    Mountainside, New Jersey, 07092

  • Kessler Foundation

    West Orange, New Jersey, 07052

Other trials in United States

About this study

Official title: Applying Cogmed to Improve Working Memory Abilities After Traumatic Brain Injury

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.

Being tested
Cogmed
Keywords
Working Memory
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CogmedBehavioural

Study groups in NCT02305212
Study groupRoleWhat they receive
CogmedExperimentalCogmed 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.
Receives: Behavioral: Cogmed
Wait listNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in scores on standardized tests of working memory

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

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

Secondary outcomes (3)

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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2014 (estimated)
  2. Study startDec 2013
  3. Primary completion2 Jun 2016
  4. Study completion2 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02305212
Sponsor's protocol ID
786-13 Cog
Acronym
Cogmed
Status last verified
Jun 2017
First submitted
19 Dec 2013
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Cogmed in people with Traumatic Brain Injury, run by Kessler Foundation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in scores on standardized tests of working memory (time frame: Three points in time: Baseline assessment, Week 7 and Week 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02305212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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