Neurofeedback for Bipolar Disorder

Официальное название

Real-time fMRI Neurofeedback as Treatment for Inter-critical Mood Symptoms in Bipolar Disorder : a Randomized Controlled Multicentric Trial

Обзор

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.

Вмешательства

• Другое Real-time fMRI Neurofeedback
  Neurofeedback with real-time fMRI is a recent technique that allows to record the BOLD signal from a particular brain region and to display it back in real-time to the participant. With this feedback on brain activity, subjects can learn to control the activity of selected brain areas. Trial after trial, participants develop their individual strategies to voluntarily regulate the signal. The main objective of the neurofeedback training is that the participant develops an enhanced ability to exer

Первичные конечные точки

• Changes in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [Срок оценки: Baseline, 3 weeks.]

Вторичные конечные точки (12)

• Montgomery and Asberg Depression Rating Scale (MADRS) [Срок оценки: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.]
• Young Mania Rating Scale (YMRS) [Срок оценки: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.]
• Bipolar Depression Rating Scale (BDRS) [Срок оценки: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.]
• State-Trait Anxiety Inventory (STAI A-B) [Срок оценки: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.]
• Multidimensional Assessment of Thymic States - MAThyS [Срок оценки: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.]
• Affective Intensity Measure - AIM [Срок оценки: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.]
• Affective Lability Scale - ALS [Срок оценки: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.]
• Cognitive Emotion Regulation Questionnaire - CERQ [Срок оценки: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.]
• Quality of life scale - QOLS [Срок оценки: Baseline, 3 weeks, and 4, 8 weeks after the end of the training. .]
• Five Facets Mindfulness Questionnaire - FFMQ [Срок оценки: Baseline, 3 weeks and 4, 8 weeks after the end of the training.]
• Global functioning assessment - GAF scale [Срок оценки: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.]
• Questionnaire of Adherence to the technology [Срок оценки: Baseline, 3 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Albert Chenevier — Créteil

Идентификаторы

NCT: NCT05802446 · APHP180597

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗