Neurofeedback for Bipolar Disorder

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called neurofeedback to help people with Bipolar Disorder (BD) manage their ongoing mood symptoms. Many individuals with BD experience periods of depression or anxiety even when they are not having full-blown mood episodes. The researchers want to see if a special type of brain training, using real-time MRI technology, can help patients learn to better control their emotional responses and reduce these residual symptoms.

To participate, individuals must be between 18 and 65 years old, diagnosed with Bipolar Disorder I or II, and have experienced stable moods for at least three months. They should also have some lingering depressive symptoms, while being on a consistent medication regimen. Throughout the study, participants will engage in brain training exercises focused on emotional imagery while continuing their usual treatment. Those involved will also undergo assessments to track any changes in their mood and brain function. It’s important to note that this study is not yet recruiting participants, but it aims to explore a promising new way to support individuals with BD in managing their emotional health.

Gender

ALL

Eligibility 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