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Neurofeedback for Bipolar Disorder

RecruitingNAAges 18 Years - 65 YearsAllAssistance Publique - Hôpitaux de Paris
NCT05802446 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Real-time fMRI Neurofeedback
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Where

1 site
Albert Chenevier
Créteil, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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