An interventional study of Repetitive Transcranial Magnetic Stimulation and Alpha-down EEG Neurofeedback in Depression - Major Depressive Disorder, sponsored by Massachusetts General Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to is to learn whether adding EEG neurofeedback (NFB) to repetitive transcranial magnetic stimulation (rTMS) is safe and feasible for adults with major depressive disorder (MDD). The study will also explore whether combining NFB with TMS may improve depression symptoms and change brain activity related to mood, focus, and rumination. The main questions it aims to answer are:
Researchers will compare 3 groups (TMS only, neurofeedback only, and TMS combined with neurofeedback) to see if combining neurofeedback with TMS will produce greater changes in symptoms than either treatment alone.
Participants will:
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 20 is below the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
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Exclusion Criteria:
Participants will receive treatment-as-usual repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC) for five consecutive weekdays (Monday through Friday). No study neurofeedback intervention will be provided in this arm.
Device: Repetitive Transcranial Magnetic Stimulation
Participants will receive standard of care rTMS targeting the left dorsolateral prefrontal cortex (DLPFC), administered daily (Monday through Friday) for five sessions. Neurofeedback training will also be conducted daily for five sessions during the same week. Each neurofeedback session will occur 30 minutes following the rTMS session and will last approximately 20 minutes. Neurofeedback will target downregulation of the alpha frequency band (8-12 Hz) using EEG electrodes at Pz, A1, and A2.
Device: Repetitive Transcranial Magnetic Stimulation · Device: Alpha-down EEG Neurofeedback
Participants will receive five consecutive weekday sessions of alpha-down EEG neurofeedback (Monday through Friday), with each session lasting approximately 20 minutes. Neurofeedback will target downregulation of the alpha frequency band (8-12 Hz) using EEG electrodes at Pz, A1, and A2. No rTMS will be administered as part of the study intervention in this arm.
Device: Alpha-down EEG Neurofeedback
Repetitive Transcranial Magnetic Stimulation (rTMS) will be delivered using a MagVenture device targeting the left dorsolateral prefrontal cortex (dlPFC). TMS is delivered through magnetic pulses which induce electrical currents in the brain. TMS will be administered once a day, for 5 consecutive days.
Alpha-down EEG neurofeedback (NFB) will be administered using EEGer 4.4.0 software with electrodes placed at Pz, A1, and A2. Participants will receive visual feedback while training to downregulate alpha-band EEG activity (8-12 Hz). Neurofeedback training will be administered once a day, for 5 consecutive days.
Feasibility and Tolerability of NFB and rTMS Interventions
The primary outcome measure will be measured through session completion rates, adverse event frequency, and participant satisfaction.
Time frame: From enrollment to the end of treatment after 6 days.
Change in Depression Symptom Severity as Measured by the Hamilton Depression Rating Scale
Changes in depressive symptom severity will be assessed by comparing baseline and post-treatment scores of the Hamilton Depression Rating Scale (HAM-D). The HAM-D measures the severity of depression based on observations made by trained personnel during a clinical interview. Scores range from 0 to 52, with higher scores representing greater depression symptom severity.
Time frame: From enrollment to the end of treatment after 6 days.
Changes in Rumination
Changes in rumination will be assessed by comparing baseline and post-treatment scores of the Ruminative Responses Scale (RRS). The Ruminative Responses Scale measures an individual's tendency to repetitively think about negative emotions and engage in self-critical thinking. Scores range from 22 to 88, with higher scores indicating greater levels of rumination.
Time frame: From enrollment to the end of treatment after 6 days.
Change in Emotion Regulation
Changes in emotional regulation will be assessed through the baseline and post-treatment scores of the Emotion Regulation Questionnaire (ERQ). The Emotion Regulation Questionnaire measures cognitive reappraisal and expressive suppression. Scores range from 10 to 70, with higher scores indicating frequent application of emotion regulation strategies.
Time frame: From enrollment to the end of treatment after 6 days.
Changes in Attentional Control
Changes in attentional control will be measured through comparing baseline and post-treatment Emotional Stroop task scores. Emotional Stroop measures attentional bias towards emotional stimuli.
Time frame: From enrollment to the end of treatment after 6 days.
Changes in Alpha-Band EEG Power and Connectivity
Alpha-band EEG activity will be assessed during EEG recordings. Changes in 8-12 Hz alpha-band power and connectivity from baseline to post-treatment will be measured as neurophysiological change.
Time frame: From enrollment to the end of treatment after 6 days.
Change in Depression Symptom Severity as Measured by the Beck Depression Inventory
Changes in depression symptom severity will be assessed by comparing baseline and post-treatment Beck Depression Inventory (BDI) scores. The Beck Depression Inventory is a self-report questionnaire designed to assess the severity of depressive symptoms. Scores range from 0 to 63, with higher scores indicating greater depression symptom severity.
Time frame: From enrollment to the end of treatment after 6 days.
Changes in Alcohol Use Behavior
Changes in alcohol use behavior will be characterized by comparing baseline and post-treatment scores of the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C). The Alcohol Use Disorders Identification Test-Consumption measures the frequency and quantity of drinking. Scores range from 0 to 12, with higher scores indicating hazardous drinking behaviors.
Time frame: From enrollment to the end of treatment after 6 days.
No study locations are listed for this record.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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