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NCT Number: NCT05802446

Neurofeedback for Bipolar Disorder

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Chenevier

Créteil, val-de-marne, 94000, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real-time fMRI Neurofeedback

Other

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 exert control over activity in the target area(s) even without feedback. By manipulating targeted brain circuits, this training can induce modifications in particular behaviors and promote selective plasticity within the corresponding brain networks.

Primary outcomes

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

    Time frame: Baseline, 3 weeks.

    Evaluation of depressive symptoms. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.

Secondary outcomes

  1. Montgomery and Asberg Depression Rating Scale (MADRS)

    Time frame: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.

    Evaluation of depressive symptoms. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.

  2. Young Mania Rating Scale (YMRS)

    Time frame: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.

    Evaluation of manic symptoms. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.

  3. Bipolar Depression Rating Scale (BDRS)

    Time frame: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.

    Evaluation of bipolar depression. Total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.

  4. State-Trait Anxiety Inventory (STAI A-B)

    Time frame: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.

    Evaluation of trait and state anxiety. Total score ranging from 20 to 80 for both subscales, with higher scores indicating a greater severity of symptoms.

  5. Multidimensional Assessment of Thymic States - MAThyS

    Time frame: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.

    Evaluation of thymic state. Total score ranging from 0 to 200, lower scores indicate general inhibition, and higher scores indicate general excitation. A more descriptive approach can be done by analysing the sub-score.

  6. Affective Intensity Measure - AIM

    Time frame: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.

    Evaluation of emotion reactivity. Total score ranging from 20 to 120, with higher scores indicating higher strength or intensity of people's emotional experiences.

  7. Affective Lability Scale - ALS

    Time frame: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.

    Evaluation of mood lability. Total score ranging from 0 to 162, with higher scores indicating greater affective lability.

  8. Cognitive Emotion Regulation Questionnaire - CERQ

    Time frame: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.

    Evaluation of emotion regulation abilities. Subscales scores ranging from 4 to 20, with higher subscale scores indicating greater use of a specific cognitive strategy.

  9. Quality of life scale - QOLS

    Time frame: Baseline, 3 weeks, and 4, 8 weeks after the end of the training. .

    Quality of life assessment. Score ranging from 1 to 5, 5 indicating better quality of life

  10. Five Facets Mindfulness Questionnaire - FFMQ

    Time frame: Baseline, 3 weeks and 4, 8 weeks after the end of the training.

    Evaluation of trait mindfulness. Total score ranging from 39 to 195, higher scores are indicative of someone who is more mindful in their everyday life

  11. Global functioning assessment - GAF scale

    Time frame: Baseline, 3 weeks, and 4, 8 weeks after the end of the training.

    Evaluation of global functioning. Total score ranging from 0 to 100, higher scores indicating better global functioning.

  12. Questionnaire of Adherence to the technology

    Time frame: Baseline, 3 weeks.

    Evaluation of the score of the acceptability of neurofeedback. Total score ranging from 6 to 42, higher scores indicating better acceptability of the technology.

  13. Self-efficacy scale

    Time frame: Baseline, 3 weeks.

    Evaluation of personal efficiency. Total score ranging from 21 to 105, higher scores indicating stronger belief that one's actions are responsible for successful outcomes.

  14. The Ekman facial recognition test

    Time frame: Baseline, 3 weeks.

    Emotion recognition evaluation. Cognitive task

  15. The affective bias task

    Time frame: Baseline, 3 weeks.

    Evaluation of emotional bias. Cognitive task

  16. The Test battery for Attentional Performance (TAP)

    Time frame: Baseline, 3 weeks.

    Evaluation of attention. Cognitive task

  17. The choice reaction task

    Time frame: Baseline, 3 weeks.

    Evaluation of mindwandering, meta-awareness and ruminations. Cognitive task

  18. MRI T1-T2 weighted scan

    Time frame: Baseline, 3 weeks

    Evaluation of grey and white matter (micro)structure. MRI measurement

  19. MRI diffusion weighted scan

    Time frame: Baseline, 3 weeks

    Evaluation of grey and white matter (micro)structure. MRI measurement

  20. functional MRI resting-state scan

    Time frame: Baseline, 3 weeks

    Evaluation of brain functional connectivity. MRI measurement

Study contacts

Contact information is provided by the study sponsor or research team.

Josselin HOUENOU, Professor (MD, PhD)

CONTACT

[email protected]

(+33)1 49 81 30 51

Pauline Favre, Associate researcher (PhD)

CONTACT

[email protected]

(+33)1 69 08 24 81

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: NEUROFEED-BD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2023
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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