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

Sponsor
Bradley Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01954680
Collaborator
National Institute of Mental Health (NIMH) (NIH)
40
Enrollment
1
Location
2
Arms
61
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: COGFLEX-skill building levels
  • Behavioral: COGFLEX-control condition
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
R21 phase was an open phase 1a trial for feasibility and acceptability with enrollment goal including intervention development of 20. R33 phase enrollment goal of 40 including double-blind placebo-controlled randomized trial of 2 versions of video game potential intervention.R21 phase was an open phase 1a trial for feasibility and acceptability with enrollment goal including intervention development of 20. R33 phase enrollment goal of 40 including double-blind placebo-controlled randomized trial of 2 versions of video game potential intervention.
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Neither participant nor independent evaluator knows group assignment in R33 phase randomized controlled trial.
Primary Purpose:
Treatment
Official Title:
COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder
Study Start Date :
Aug 1, 2013
Anticipated Primary Completion Date :
Sep 1, 2018
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in functional magnetic resonance imaging (fMRI) brain activation [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).

    Secondary Outcome Measures

    1. Change in Clinician global Impression Improvement-Irritability [Change from week 1 to week 8]

      Clinician global Impression Improvement-Irritability

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bradley Hospital East Providence Rhode Island United States 02915

    Sponsors and Collaborators

    • Bradley Hospital
    • National Institute of Mental Health (NIMH)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bradley Hospital
    ClinicalTrials.gov Identifier:
    NCT01954680
    Other Study ID Numbers:
    • 0195-07 COGFLEX
    • R21MH096850
    • R33MH096850
    First Posted:
    Oct 7, 2013
    Last Update Posted:
    Jan 18, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by Bradley Hospital
    bipolar disorder
    child
    adolescent
    Additional relevant MeSH terms:
    Disease
    Bipolar Disorder

    Study Results

    No Results Posted as of Jan 18, 2018