Clinical trial Recruiting at 1 site Interventional Ages 22 to 60

EEG-Guided TMS for Adults With Depression

Official title: Closed-Loop Electroencephalography Optimized Transcranial Magnetic Stimulation Pilot Study for Advanced Treatment Outcomes in Adults With Major Depressive Disorder

Run by Mayo Clinic · NCT07862205 · Data updated 2026-11-12

This study tests whether delivering intermittent theta burst stimulation (iTBS) timed to brain waves using EEG can improve treatment for adults with major depressive disorder who have not responded to usual antidepressants.

Quick facts

Study typeInterventional
Ages22 Years to 60 Years
SexAll
Enrollment60 (estimated)
SponsorMayo Clinic
Academic / other
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedNovember 2, 2026
Main results expectedNovember 2029
Study endsNovember 2029
Registry record updatedNovember 3, 2026
Trial IDNCT07862205 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 22-60 with a confirmed major depressive episode who have not adequately responded to standard antidepressants.

Probably not a fit

Patients with non-depression psychiatric conditions, substantial MRI contraindications, or unstable psychotropic medication changes may be less likely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind study compares three closed-loop TMS approaches in adults with major depressive disorder who did not respond adequately to antidepressants. All participants receive active iTBS delivered to the left dorsolateral prefrontal cortex with EEG guidance, but stimulation timing differs: at theta troughs, at theta peaks, or at random phases. Participants undergo 6 weeks of daily sessions (5 days per week), with weekly and then monthly assessments of depressive symptoms using HDRS, MADRS, PHQ-9, and GAD-7, while blinded raters monitor outcomes. Treatment uses a MagVenture system with neuronavigation and EEG caps to support blinding and precise targeting, with follow-up to assess delayed responses.

Why it matters

Potential benefit: If successful, the approach could lead to more effective, personalized timing of TMS for depression.

How similar studies have gone: Previous TMS studies show promise for iTBS in depression; this study tests whether EEG-guided timing can enhance effects.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Outpatients
* Voluntary patient seeking treatment with the capacity to consent
* 22-60 years of age
* Have Major Depressive Disorder (MDD) single or recurrent episodes confirmed with the Mini-International Neuropsychiatric Interview (MINI)57
* Failed to achieve a clinical response to an adequately dosed antidepressant as assessed with an Antidepressant Treatment History Form score of 3 or greater in the current episode or have had 2 separate trials of antidepressants that were intolerable
* Have a score of 18 or higher on the Hamilton Depression Rating Scale (17 item) HDRS
* In a current episode of MDD with duration of at least 4 weeks but less than 2 years
* Have no initiation or dose change in any psychotropic medication or for the 4 weeks prior to screening
* Have no clinically significant changes (as determined by the study investigators) in psychotherapeutic interventions for the 4 weeks prior to screening Can safely undergo TMS treatment based on the TMS Adult Safety Screen questionnaire
* On a medically acceptable form of birth control if capable of becoming pregnant
* Are able to adhere to the protocol and treatment schedule
* Currently and throughout study participation is under the care of a licensed psychiatrist and/or other mental health care provider and agrees to promptly inform the investigator or study staff of any change in such provider(s).
* Agrees to allow any and all forms of communication between the investigators and study staff with any healthcare provider who has provided service to the patient/participant within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event.
* Agrees to provide the name and verifiable contact information (email and mailing addresses, mobile and land-line phone numbers, as applicable) of at least two persons 22 years or older who reside within reasonable driving time of the patient's home address. Participant also agrees that research personnel are at liberty to contact these individuals if the participant is unable to be contacted.

Exclusion Criteria:

* Have a history of a substance use disorder (including alcohol)
* Within the past 3 months have a major medical illness, intracranial lesion or increased intracranial pressure, prior ischemic or hemorrhagic stroke, neurologic conditions with structural cerebral damage, stroke, multiple sclerosis, traumatic brain injury, epilepsy, a personal history of a seizure, or individuals with a family history of epilepsy or seizure in a first degree relative (please note that an individual with a first-degree relative with a history of epilepsy, or one or more seizures does not need to be excluded if the cause of epilepsy or seizure(s) is non-genetic (i.e., "non-idiopathic"), Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers), moderate to severe heart disease, cardiac pacemaker, implanted devices, or implanted medication pumps
* Contraindications for TMS or MRI
* Have active suicidal intent, as determined by the Principal Investigator (PI) and/or is considered a moderate-high risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate risk) or YES to Question 4, 5, or 6 (High risk))4 by the PI. (Columbia Suicide Severity Rating Scale.
* Pregnant and lactating patients
* As determined by the Principal Investigator (PI), has: (a) a lifetime history of mania or hypomania symptoms from any cause; (b) a medical condition or diagnosis, within 1 year of screening, that seems somewhat likely to cause such symptoms; or (c) scores 12 on the Young Mania Rating Scale.
* Based on the MINI interview have a lifetime diagnosis of bipolar I, bipolar II, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or any current psychotic symptoms.
* Patients taking bupropion/Wellbutrin or antipsychotics are excluded

Where it's running

  • Mayo Clinic
    Rochester, Minnesota, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.