Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study (COGFLEX)

January 16, 2018 updated by: Bradley Hospital

COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder

The main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents.

In the study, children and adolescents with bipolar disorder will come to our lab at Bradley Hospital 2-times per week for 8-weeks to "play" a custom computer "game" designed to retrain the brain--to build a skill that my work has shown is impaired in children/adolescents with bipolar disorder.

Before and after this 8-week trial, children will have a special magnetic resonance imaging (MRI) scan.

This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.

If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prior studies have shown that "computer assisted cognitive remediation"--meaning using computer "games" to build up a skill that has been shown to be impaired in a specific disorder--can result in improvement in psychiatric illnesses--including schizophrenia.

This will be the first National Institute of Mental Health (NIMH)-funded study to use this "retrain your brain" approach in children and adolescents with bipolar disorder.

During this study, we are seeking 40 children and adolescents with bipolar disorder to:

  • come to our lab at Bradley Hospital in East Providence R.I. twice per week (each lasting 1 hour) to "play" a special computer game for a total of 8 weeks
  • to have a special MRI before and after this 8-week trial to see if our "game" improves brain activity
  • it does NOT matter if your child is already on medications--they can continue during this study
  • all children/adolescents with bipolar disorder are welcome--as long as they do NOT have implanted metal (no braces, no cochlear implants, etc) because of magnetic resonance imaging (MRI) safety.

This is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes.

If it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Recruiting
        • Bradley Hospital
        • Contact:
        • Principal Investigator:
          • Daniel Dickstein, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 7-17 years old
  • bipolar disorder type I preferred (at least 1 week of mania)

Exclusion Criteria:

  • no implanted metal (no braces, no cochlear implants)
  • can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic disorder
  • no active drug/alcohol abuse/dependence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COGFLEX-skill building levels
In the R33, children will be randomized to receive either COGFLEX with skill-building levels or just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks.
Behavioral: COGFLEX-skill building levels

COGFLEX--in English-- is a computer game designed to build up a specific skill that our work has shown is impaired in children and adolescents with bipolar disorder).

In the R33, children will be randomized to receive either COGFLEX with skill-building levels or COGFLEX-control condition which is just baseline/non-probabilistic trials.

All children will play COGFLEX twice per week for 8-weeks.

This same approach has shown great success in many psychiatric disorders including schizophrenia.

This is the first such study in children/adolescents with bipolar disorder.

Other Names:
  • COGFLEX is a computer assisted cognitive remediation
Experimental: COGFLEX-control condition
In the R33, children will be randomized to receive either COGFLEX with skill-building levels or the control condition--which is just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks.
Behavioral: COGFLEX-control condition
In the R33, the control condition will be the same COGFLEX "game"--but just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional magnetic resonance imaging (fMRI) brain activation
Time Frame: Change from week 1 to week 8
We will compare functional magnetic resonance imaging (fMRI) brain activation from week 1 (before intervention starts) to week 8 (after intervention is complete).
Change from week 1 to week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinician global Impression Improvement-Irritability
Time Frame: Change from week 1 to week 8
Clinician global Impression Improvement-Irritability
Change from week 1 to week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bradley Hospital

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Daniel Dickstein, M.D., Bradley Hospital/Alpert Medical School of Brown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0195-07 COGFLEX
  • R21MH096850 (U.S. NIH Grant/Contract)
  • R33MH096850 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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