Using brain stimulation to improve decision-making in patients with mood disorders
Use of tDCS (Transcranial Direct Current Stimulation) Applied to the Orbitofrontal Cortex to Improve Risky Decision-making in a Clinical Population: a Proof-of-concept Study
This study is testing if a type of brain stimulation can help people with mood disorders make better decisions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06110559 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of transcranial direct current stimulation (tDCS) applied to the orbitofrontal cortex on decision-making abilities in patients with mood disorders. Participants will be randomly assigned to receive either active tDCS or a placebo stimulation, with their decision-making assessed using the Iowa Gambling Task. The study will also explore the relationship between emotional changes and decision-making, as well as the impact of tDCS on cognitive functions such as motor inhibition and cognitive interference. It is a single-blind, randomized controlled trial conducted at a psychiatric hospital in Paris.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 diagnosed with unipolar or bipolar depressive disorder.
Not a fit: Patients currently experiencing a hypomanic or manic episode or those undergoing electroconvulsive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance decision-making capabilities in patients suffering from mood disorders, potentially reducing their risk of suicide.
How similar studies have performed: While the use of tDCS in psychiatric populations is being explored, this specific application targeting decision-making in mood disorders is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients under consideration should either be receiving outpatient or inpatient care. * Patients must be between the ages of 18 and 65, inclusive. * According to DSM-5 criteria, patients should be diagnosed with either unipolar or bipolar depressive disorder. This includes individuals currently experiencing a characterized depressive episode with mild to moderate intensity, those in partial remission, or those in full remission. * Patients must have provided informed consent. * Patients should be enrolled in a social security plan. Exclusion Criteria: * Patient unwilling to participate in the research. * Non-French-speaking individuals. * Individuals deprived of liberty by judicial or administrative decision, such as those under guardianship or curatorship or involuntarily hospitalized. * Pregnant or breastfeeding women. * Current hypomanic or manic episode as per DSM-5 criteria due to motor agitation issues. * Ongoing electroconvulsive therapy (ECT) treatment or within the last 6 months. * Patients with active implantable medical devices. * Epilepsy.
Where this trial is running
Paris
- GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne - CMME — Paris, France (Recruiting)
Study contacts
- Principal investigator: Michel DANON, MD — GHU Paris Pyschiatrie & Neurosciences
- Study coordinator: Michel DANON, MD
- Email: m.danon@ghu-paris.fr
- Phone: +33625201929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.