Maintenance rTMS for Depression (Maitr-De)

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06938841
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation (TMS) - Standard maintenance rTMS: — DEVICE
    In this approach, patients who were treated with rTMS five days per week during their acute episode receive less frequent treatments during a taper period (for example treatment three days per week followed by two sessions per week) with a gradual transition into a maintenance schedule. For example, the maintenance schedule might begin with a single weekly session for one or two months and then the intensity is reduced to one session every two weeks (and possibly then one session every three or four weeks).
  • Transcranial Magnetic Stimulation (TMS) - Clustered maintenance rTMS: — DEVICE
    Clustered maintenance rTMS typically involves around 4 TMS sessions applied over 2 days, at 1-month intervals. Our team initially developed this approach based upon preclinical TMS studies (for example (Maeda et al. 2000)) suggesting that rTMS treatment effects may accumulate when applied over multiple sessions in a shorter period of time (Maeda et al. 2000).
  • Transcranial Magnetic Stimulation (TMS) -- Sham maintenance rTMS — DEVICE
    Sham treatment will be administered as either standard or clustered maintenance rTMS for 6 months period using a sham coil. The intervention target will be located via a Brainsight TMS Navigator (Brainsight, Montreal, Canada). For safety reasons, the individual TMS intensity will be limited to 130% of the individual resting motor threshold.

Study Details

Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising intervention for treatment-resistant depression (TRD), yet substantial uncertainties persist regarding its efficacy as a maintenance treatment. This prospective study seeks to investigate the efficacy of maintenance rTMS in individuals with TRD who have previously responded to an acute course of rTMS. In the R61 phase of the study, we will recruit 75 participants across three study sites, the University of California San Diego, Weill Cornell Medicine, and Australian National University, into a double-blind, three-arm maintenance treatment trial. In this trial, participants will be randomized to receive either standard maintenance rTMS, clustered maintenance rTMS, or sham maintenance rTMS for a duration of 6 months. Our primary aim is to examine the efficacy of maintenance rTMS on sustaining connectivity between the dorsolateral prefrontal cortex (DLPFC) and subgenual cingulate cortex (SGC) measured through concurrent TMS and electroencephalography (TMS-EEG) at baseline and every six weeks throughout the 6-month treatment period. We will also assess changes in depressive symptom severity using clinical scales, including the Montgomery-Asberg Depression Rating Scale (MADRS) as a secondary outcome measure. It is hypothesized that stimulation with clustered maintenance rTMS will demonstrate superiority in sustaining DLPFC-SGC connectivity compared with standard maintenance rTMS and sham maintenance rTMS

Key Dates

Start date
Apr 1, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Mar 31, 2027

Study Design

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

Arms

  • Experimental: Clustered maintenance rTMS
    Clustered maintenance treatment involves administering four sessions of rTMS over a two-day span, conducted once per month for six months.
  • Active Comparator: Standard maintenance rTMS:
    Standard maintenance rTMS involves a course of rTMS with once-weekly sessions for 6 months.
  • Placebo Comparator: sham maintenance rTMS
    Somatosensory-matched placebo rTMS is delivered according to either standard or clustered maintenance schedules over a six-month period (50/50% allotment). Patient's maintenance protocol parameters will otherwise mirror those used during their acute treatment with identical cortical targets, stimulation intensity, frequency, and duration. Sham TMS-EEG will be conducted by rotating the coil 90 degrees while maintaining contact with the scalp. This standard practice prevents current induction while replicating the auditory click associated with TMS, ensuring comparable EEG recordings

Primary Outcome Measure

Aim: To evaluate the effects of two active rTMS maintenance treatments (i.e., standard and clustered) compared to sham maintenance rTMS on DLPFC-SGC connectivity. [ Time Frame: 6-months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92127
Bianca Bacio
[email protected]
858-657-6152
Zafiris J Daskalakis, MD. Ph.D. (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Megan Johnson
[email protected]
646-962-2900
Conor M Liston, PhD, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California, San Diego· San Diego, CAWeill Cornell Medicine· New York, NY

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