Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 7 - 17 |
| Updated: | 1/20/2018 |
| Start Date: | August 2013 |
| End Date: | September 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
East Providence, Rhode Island 02915
Principal Investigator: Daniel Dickstein, M.D.
Phone: 401-432-1600
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