Informations générales (source: ClinicalTrials.gov)
Real-time fMRI Neurofeedback as Treatment for Inter-critical Mood Symptoms in Bipolar Disorder : a Randomized Controlled Multicentric Trial
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mai 2024
septembre 2026
11 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GHU PARIS PSY ET NEUROSCIENCES | HOUENOU Josselin | 01/11/2025 07:41:40 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 01/11/2025 07:41:40 | Contacter | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Albert Chenevier - 94000 - Créteil - Val-de-marne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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