Real-time fMRI Neurofeedback to Reduce Residual Symptoms in Bipolar Disorder
Real-time fMRI Neurofeedback as Treatment for Inter-critical Mood Symptoms in Bipolar Disorder : a Randomized Controlled Multicentric Trial
This trial will try using real-time fMRI neurofeedback to help adults with bipolar disorder reduce persistent depressive and emotional symptoms between mood episodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil, val-de-marne) |
| Trial ID | NCT05802446 on ClinicalTrials.gov |
What this trial studies
This interventional trial uses real-time functional MRI neurofeedback to train adults with bipolar I or II to self-regulate brain activity linked to emotion, aiming to reduce residual depressive or anxiety symptoms. Eligible participants are aged 18–65, have been free of a major mood episode for at least three months, have low but persistent depressive symptoms, and are on a stable dose of mood stabilizer. The intervention consists of fMRI neurofeedback sessions with MRI safety screening and exclusion of major comorbid psychiatric disorders or substance abuse (except tobacco/cannabis). Outcomes will include changes on standard symptom scales (e.g., MADRS, YMRS) and measures of daily functioning.
Who should consider this trial
Good fit: Adults 18–65 with bipolar I or II who have been stable (no major mood episode for ≥3 months), have residual depressive symptoms (MADRS > 5 but not severe), and are on a stable mood stabilizer dose are ideal candidates.
Not a fit: People currently in a major manic or depressive episode, with major psychiatric comorbidities, active substance abuse (other than tobacco or cannabis), or any MRI contraindication are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could give patients a non-drug option to reduce lingering depressive or emotional symptoms and improve day-to-day functioning.
How similar studies have performed: Small studies of real-time fMRI neurofeedback have shown promise for depression and emotion regulation, but its use specifically for residual symptoms in bipolar disorder is relatively novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with bipolar disorder I or II (DSM-5 criteria); * Aged between ≥ 18 and ≤ 65; * Absence of major mood episode for at least 3 months before inclusion (MADRS scores \< 12; YMRS score \< 10); * Presence of residual depressive symptoms, as assessed by the MADRS (score \> 5); * Stabilized dose of mood stabilizer medication for at least 3 months before inclusion. * Written consent * Affiliation to a social security system * Effective contraception for women of childbearing age Exclusion Criteria: * Severe physical disorders that may be life-threatening; * Major psychiatric (Axis 1) comorbidities except for anxiety disorders; * Any current substance abuse except for tobacco or cannabis. Substance abuse will be defined by the DSM V criteria; * Exclusion criteria applicable to MRI Panic disorder, claustrophobia, epilepsy Pace maker or neuronal stimulator, intraocular or intracerebral metallic foreign body, cochlear implant, cardiac valve or metallic surgical arterial material, non removable removable magnetizable metallic material * Somatic disorder that may affect cognitive abilities and brain structures (e.g., HIV infection, MS, lupus, Parkinson's disease, epilepsy, dementia...); * Ongoing non-pharmacological treatment: structured psychotherapeutic interventions (Cognitive Behavioral Therapy - CBT, Interpersonal and Social Rhythm Therapy - IPSRT) as well as brain stimulation techniques (Electroconvulsive Therapy - ECT, Transcranial Magnetic Stimulation - TMS, Deep Brain Stimulation - DBS); * Subject included in clinical and / or therapeutic experimentation in progress. * Patients under legal protection * Prisoners * Pregnancy * Breastfeeding
Where this trial is running
Créteil, val-de-marne
- Albert Chenevier — Créteil, val-de-marne, France (Recruiting)
Study contacts
- Study coordinator: Josselin HOUENOU, Professor (MD, PhD)
- Email: josselin.houenou@aphp.fr
- Phone: (+33)1 49 81 30 51
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.