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

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ClinicalTrials.gov Identifier: NCT01954680
Recruitment Status : Recruiting
First Posted : October 7, 2013
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Bradley Hospital

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
Bipolar Disorder Pediatric Bipolar Disorder Childhood-onset Bipolar Disorder 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 Type : Interventional  (Clinical Trial)
Estimated 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.

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 : August 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

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 Name: 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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Change in Clinician global Impression Improvement-Irritability [ Time Frame: Change from week 1 to week 8 ]
    Clinician global Impression Improvement-Irritability



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954680


Locations
United States, Rhode Island
Bradley Hospital Recruiting
East Providence, Rhode Island, United States, 02915
Contact: PediMIND Program    401-432-1600    pedimind@gmail.com   
Principal Investigator: Daniel Dickstein, M.D.         
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

Additional Information:
Responsible Party: Bradley Hospital
ClinicalTrials.gov Identifier: NCT01954680     History of Changes
Other Study ID Numbers: 0195-07 COGFLEX
R21MH096850 ( U.S. NIH Grant/Contract )
R33MH096850 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2013    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Bradley Hospital:
bipolar disorder
child
adolescent

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders