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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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COGFLEX: Pilot Translational Intervention of Pediatric Bipolar Disorder

Conditions
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Bipolar Disorder, Pediatric Bipolar Disorder, Childhood-onset Bipolar Disorder

Intervention / Treatment
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* Behavioral: COGFLEX-skill building levels
* Behavioral: COGFLEX-control condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COGFLEX-skill building levels<br>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<br>* 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.<br>* Other names: COGFLEX is a computer assisted cognitive remediation;|
| Experimental: COGFLEX-control condition<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional magnetic resonance imaging (fMRI) brain activation | 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 | Clinician global Impression Improvement-Irritability | Change from week 1 to week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar disorder, child, adolescent