Actively Recruiting
Neurofeedback for Bipolar Disorder
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-07-15
64
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bipolar Disorder (BD) is a severe mood disorder affecting between 1% and 3% of the general population. It is characterized by the succession of depressive and manic episodes, with periods of stabilization during which patients may present "residual" depressive or anxious symptoms, which are characterized by sadness and emotional hyper-reactivity. Although subthreshold, these residual symptoms are very disabling for their daily lives and are associated with the risk of recurrence and poor global functioning. The effect of pharmacological and psychotherapeutic treatments is demonstrated in the management of acute episodes but remains insufficient on residual symptoms. Therefore, there are so far few therapeutic options to target the inter-episode residual symptoms in BD. One novel approach is the real-time functional magnetic resonance imaging (fMRI) neurofeedback (NFB), which has already been shown to be an efficient method for self-regulating brain function, behavior and treating depression. Hypothesis/Objective : This study aims at assessing the efficacy of 3-weeks neurofeedback training with real-time fMRI on the treatment of residual mood symptoms in patients with BD. The investigators will specifically target depressive symptoms by training the patients to regulate the emotional network hemodynamic response to emotional stimuli. Method : The investigators will include 64 stabilized patients with BD. The investigators will recruit them in three French expert centers for BD and will randomly assign them to the experimental group, receiving feedback from the emotional brain network hemodynamic activity, or to the control group, receiving the signal from control brain areas not involved in emotion processing. Both groups will be trained to regulate their brain activity while they are presented with negatively valenced emotional pictures, based on the neurofeedback shown immediately after the trial. They will continue their usual treatment (as prescribed) throughout the duration of the study. Clinical scales and cognitive tests will enable us to evaluate the symptomatic, emotional, and cognitive changes after NFB training. The investigators will also measure resting-state functional connectivity and brain morphology before and after NFB to assess brain plasticity and to explore the neural mechanisms associated with successful regulation.
CONDITIONS
Official Title
Neurofeedback for Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with bipolar disorder type I or II (DSM-5 criteria)
- Aged 18 to 65 years
- No major mood episode for at least 3 months before joining (MADRS score below 12; YMRS score below 10)
- Presence of residual depressive symptoms (MADRS score above 5)
- Stable dose of mood stabilizer medication for at least 3 months before joining
- Provided written informed consent
- Affiliated with a social security system
- Effective contraception for women of childbearing age
You will not qualify if you...
- Severe life-threatening physical disorders
- Major psychiatric comorbidities except anxiety disorders
- Current substance abuse except tobacco or cannabis (per DSM V criteria)
- MRI-related exclusions: panic disorder, claustrophobia, epilepsy, pacemaker or neuronal stimulator, intraocular or intracerebral metal, cochlear implant, cardiac valve or metallic arterial surgical material, non-removable magnetizable metal
- Somatic disorders affecting cognition or brain (e.g., HIV, multiple sclerosis, lupus, Parkinson's, epilepsy, dementia)
- Current structured psychotherapy or brain stimulation treatments (CBT, IPSRT, ECT, TMS, DBS)
- Participation in other clinical or therapeutic trials
- Under legal protection
- Prisoners
- Pregnant
- Breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Albert Chenevier
Créteil, val-de-marne, France, 94000
Actively Recruiting
Research Team
J
Josselin HOUENOU, Professor (MD, PhD)
CONTACT
P
Pauline Favre, Associate researcher (PhD)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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