Effect of Neurofeedback and TMS

NCT07892287 | Not Yet Recruiting FDA Device

• 1 other identifier: 2026P000527
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• Is alpha-down neurofeedback safe, tolerable, and feasible for people with MDD?
• Does alpha-down neurofeedback improve symptoms of depression, anxiety, and difficulties with attention, emotion regulation, and rumination?
• Does combining neurofeedback with TMS produce greater changes in symptoms than either treatment alone? 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:
• Complete assessments of depression severity, anxiety, and cognitive function.
• Complete 5 treatment sessions Monday through Friday.
• Receive alpha-down neurofeedback, TMS, or both, depending on their group assignment.
• Complete EEG recordings of brain activity before and after treatment.
• Complete a questionnaire about their experience in the study.

Conditions

Depression - Major Depressive Disorder

Keywords

Neurofeedback; Transcranial Magnetic Stimulation; Depression; Treatment-Resistant Depression; Noninvasive Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment after 6 days.

Secondary Outcomes (6)

• Change in Depression Symptom Severity as Measured by the Hamilton Depression Rating Scale

  From enrollment to the end of treatment after 6 days.

• Changes in Rumination

  From enrollment to the end of treatment after 6 days.

• Change in Emotion Regulation

  From enrollment to the end of treatment after 6 days.

• Changes in Attentional Control

  From enrollment to the end of treatment after 6 days.

• Changes in Alpha-Band EEG Power and Connectivity

  From enrollment to the end of treatment after 6 days.

Other Outcomes (1)

• Changes in Alcohol Use Behavior

  From enrollment to the end of treatment after 6 days.

Study Arms (3)

TMS Only

ACTIVE COMPARATOR

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

Neurofeedback and TMS

EXPERIMENTAL

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

Neurofeedback only

EXPERIMENTAL

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

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

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.

Neurofeedback and TMS; TMS Only

Alpha-down EEG Neurofeedback DEVICE

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.

Neurofeedback and TMS; Neurofeedback only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between 18 and 65 years old.
• Have a diagnosis of Major Depressive Disorder (MDD), confirmed using standard diagnostic criteria.
• Have normal hearing and normal or corrected-to-normal vision.

You may not qualify if:

• Have ever been diagnosed with bipolar disorder, psychosis, autism spectrum disorder, or another neurodevelopmental disorder.
• Current major depressive episode with suicidal thoughts.
• Have ever had a seizure or been diagnosed with epilepsy.
• Have had a significant head injury that resulted in prolonged loss of consciousness, ongoing neurological problems, or a known structural brain abnormality.
• Are currently intoxicated, experiencing substance withdrawal, or have an unstable pattern of substance use that could make participation unsafe or interfere with the study procedures.
• Are pregnant or think you may be pregnant.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

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MeSH Terms

Conditions

Depression; Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Tracy Barbour, MD

CONTACT

(617) 726-5340; tbarbour@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share