RecruitingNot ApplicableNCT07041073

EEG-based Neurofeedback to Improve Emotion Regulation in Major Depressive Disorder: A Randomized Clinical Trial

Restoring Emotional Stability Through Neurofeedback and AI for Transformative Empowerment

Sponsor

Corporacion Parc Tauli

Enrollment

72 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)Major Depression With Comorbid Anxiety Symptoms

Summary

The goal of this clinical trial is to evaluate whether EEG-based neurofeedback targeting the emotion regulation network through swLORETA can improve emotional regulation and reduce symptoms in adults with Major Depressive Disorder (MDD) who have not responded sufficiently to first-line treatments. The main questions it aims to answer are: * Does EEG-neurofeedback improve emotional self-regulation and reduce clinical symptoms in patients with MDD with or without anxiety symptoms? * Are changes in EEG resting-state activity and stress biomarkers (e.g., cortisol) associated with clinical improvement? Researchers will compare an active neurofeedback group, a sham (placebo) neurofeedback group, and a treatment-as-usual control group to see if real-time EEG-neurofeedback leads to greater improvement in mood, emotional regulation, and neurophysiological indicators than placebo or no additional intervention. Participants will: * Receive 10 sessions of either real or sham EEG-neurofeedback (or no sessions in the control group) over 5 weeks. * Complete clinical, psychological, and neurophysiological assessments before (week 0) and after the intervention (week 6). * Provide repeated saliva samples to assess stress-related biomarkers at week 0 and week 6. * Continue their standard pharmacological treatment throughout the study.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brain-training technique called EEG-based neurofeedback to help people with major depression better manage their emotions. Neurofeedback uses real-time brainwave information shown on a screen to help patients learn to regulate their own brain activity. This is done alongside medication, not as a replacement. **You may be eligible if...** - You have been formally diagnosed with major depressive disorder (MDD) by a psychiatrist - You score at least 20 on a standard depression rating scale, indicating moderate depression - You have been on a stable dose of psychiatric medication for at least 6 weeks - You may also have anxiety symptoms, as long as depression is your primary diagnosis **You may NOT be eligible if...** - You have a history of seizures or epilepsy - You have a metal implant in your head or a pacemaker - You have a different primary psychiatric diagnosis (such as bipolar disorder or psychosis) - Your medication has changed recently (within the last 6 weeks) - You have already tried neurofeedback therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive swLORETA Z-score Neurofeedback

Participants receive 10 sessions (25 minutes each, twice per week for 5 weeks) of EEG-based neurofeedback using the NeuroGuide® software and a 24-channel EEG recording system (eego™, ANT Neuro). The neurofeedback protocol is based on real-time swLORETA Z-score training targeting brain regions involved in emotion regulation. Feedback is provided via gamified visual displays when EEG activity moves toward normative patterns. This is an operant conditioning-based protocol designed to enhance emotional self-regulation.

DEVICEYoked-sham swLORETA Z-score Neurofeedback

Participants receive 10 sessions identical in appearance and duration to the active neurofeedback condition. However, the feedback provided is not based on their own EEG activity. Instead, it is pre-recorded data from a matched participant in the active group ("yoked" design), ensuring no real-time neurophysiological modulation occurs. The same EEG equipment and visual feedback interface are used to maintain blinding.