Pure Global AI
NCT05802446Not yet recruiting

Neurofeedback for Bipolar Disorder

Real-time fMRI Neurofeedback as Treatment for Inter-critical Mood Symptoms in Bipolar Disorder : a Randomized Controlled Multicentric Trial
Assistance Publique - Hôpitaux de ParisClinicalTrials.govother
Study focus
Disease/Condition
Bipolar Disorder
Drug/Device/Intervention
Real-time fMRI Neurofeedback
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Assistance Publique - Hôpitaux de Paris
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2023
End date
Aug 01, 2025
Enrollment
64 participants
Primary outcome

Changes in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Summary

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.

ICD-10 classifications
Bipolar affective disorderBipolar affective disorder, unspecifiedOther bipolar affective disordersBipolar affective disorder, currently in remissionBipolar affective disorder, current episode mixed
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05802446
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05802446 through Pure Global AI's free database. This phase not specified trial is sponsored by Assistance Publique - Hôpitaux de Paris and is currently Not yet recruiting. The study focuses on Bipolar Disorder. Target enrollment is 64 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.