Recruiting

iTBSEEG-Guided Transcranial Magnetic Stimulation for Adults With Depression

Sponsor:

Mayo Clinic

Code:

NCT07862205

Conditions

Major Depressive Disorder (MDD)

Treatment Resistant Depression

Major Depression

Eligibility Criteria

Sex: All

Age: 22 - 60

Healthy Volunteers: Not accepted

Interventions

MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG

Study Details

Brief summary:

The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (MDD).

This is a feasibility study to test a "closed-loop" procedure which guides the timing of this FDA-cleared form of TMS. Each participant will receive an active experimental treatment, and the timing of the TMS pulses will be at one of three phases in the brain wave of interest.

Conditions

Major Depressive Disorder (MDD)

Treatment Resistant Depression

Major Depression

Study ID

NCT07862205

Start date

Nov 2, 2026

Status verified date

Oct, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 22 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Peak Theta Closed-Loop iTBS

Participants receive EEG-guided intermittent theta burst stimulation (iTBS) delivered to the left dorsolateral prefrontal cortex (DLPFC). Stimulation bursts are synchronized to the peak of the participant's individual theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total).

experimental: Trough Theta Closed-Loop iTBS

Participants receive EEG-guided iTBS delivered to the left DLPFC with stimulation bursts synchronized to the trough of individual theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total)

active comparator: Random Phase iTBS

Participants receive EEG-guided iTBS delivered to the left DLPFC with stimulation occurring at a random phase of theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total). This arm serves as the reference condition.

Interventions

MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG

The MagVenture TMS Therapy System is based on the use of intermittent theta burst stimulation, or iTBS. This novel TMS protocol delivers treatment in only 3 minutes and is based on a patterned TMS paradigm delivered to the left-dorsolateral prefrontal cortex (LDPFC) at 120% of resting motor threshold (MT). It consists of bursts of 3 pulses at 50 Hz, with bursts repeated at 5 Hz, in a duty cycle of 2s on, 8 s off, over 3 minutes and 9 seconds, and a total of 600 pulses.

For peak or trough iTBS, stimulation will consist of 3 pulses at 50 Hz delivered at intervals of their individual theta rhythm (e.g. 200 msec for a 5Hz oscillation) followed by an 8 second rest period. The pulses will be aligned to either the peak or the trough of the theta rhythm at the beginning of each pulse train. The TMS therapy will be delivered to the Left DLPFC at 120% of resting motor threshold (MT) daily for 5 days per week, for 6 weeks.

Primary outcome measure

Feasibility of closed-loop EEG guided iTBS in adult participants with MDD. [ Time Frame: 6 weeks and 12 weeks post-treatment ]

Central Contacts and Locations

Central contacts

Courtney Caves

507-255-0624 wolf.courtney@mayo.edu

Sarah Purdy

507-266-3303 purdy.sarah@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Courtney Caves

507-255-0624 CLEOPATRA@mayo.edu

Sarah Purdy

507-266-3303 CLEOPATRA@mayo.edu

Principal Investigator:

Paul Croarkin, DO, MS

More Information

Sponsor

Mayo Clinic

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

Transcranial Magnetic Stimulation (TMS)
Major Depressive Disorder
Intermittent Theta Burst Stimulation (iTBS)
Adults with MDD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.