EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07862205
Status
Not Yet Recruiting

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Conditions

  • Major Depression
  • Major Depressive Disorder (MDD)
  • Treatment Resistant Depression

Eligibility Criteria

Sex
ALL
Age
22 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Oct 7, 2026
Start date
Nov 30, 2026
Status verified
Oct 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Courtney Caves
[email protected]
507-255-0624
Sarah Purdy
[email protected]
507-266-3303
Paul Croarkin, DO, MS (PRINCIPAL_INVESTIGATOR)

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