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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bradley Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bradley Hospital
ClinicalTrials.gov Identifier:
NCT01954680
First received: September 20, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Bipolar Disorder
Pediatric Bipolar Disorder
Childhood-onset Bipolar Disorder
Behavioral: COGFLEX-skill building levels
Behavioral: COGFLEX-control condition
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Bradley Hospital:

Primary Outcome Measures:
  • Change in functional magnetic resonance imaging (fMRI) brain activation [ Time Frame: Change from week 1 to week 8 ] [ Designated as safety issue: No ]
    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:
  • Change in Clinician global Impression Improvement-Irritability [ Time Frame: Change from week 1 to week 8 ] [ Designated as safety issue: No ]
    Clinician global Impression Improvement-Irritability


Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Daniel Dickstein, M.D. Bradley Hospital/Alpert Medical School of Brown University
  More Information

Additional Information:
No publications provided

Responsible Party: Bradley Hospital
ClinicalTrials.gov Identifier: NCT01954680     History of Changes
Other Study ID Numbers: 0195-07 COGFLEX, R21MH096850
Study First Received: September 20, 2013
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Bradley Hospital:
bipolar disorder
child
adolescent

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014