Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study (NCT01954680) | Clinical Trial Compass
UnknownPhase 1
Retrain Your Brain in Children/Adolescents With Bipolar Disorder: A Pilot Study
United States40 participantsStarted 2013-08
Plain-language 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.
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in functional magnetic resonance imaging (fMRI) brain activation