Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT07528157
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalized iTBS — DEVICE
    Intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex using individualized pulse count (600, 1200, or 1800 pulses) and intensity (90% or 120% rMT) determined by EL-TEP screening.
  • Non-Personalized iTBS — DEVICE
    Intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex at fixed parameters: 1800 pulses, 120% resting motor threshold.
  • Sham iTBS — DEVICE
    Inactive sham stimulation using a shielded coil with electrical scalp stimulation to mimic sensory experience of active iTBS.

Study Details

This study tests whether a brain stimulation treatment for depression called intermittent theta burst stimulation (iTBS) can be improved by tailoring it to each individual. A type of brain signal measured with electroencephalography (EEG) after a single pulse of brain stimulation, called an early local TMS-evoked potential (EL-TEP), is used to identify which stimulation settings work best for each participant. The investigators will compare individualized (personalized) iTBS settings to standard (non-personalized) settings and to inactive (sham) stimulation. Participants are adults with treatment-resistant depression.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Personalized iTBS
    Participants receive 10 sessions of iTBS using individually selected pulse count and intensity parameters identified during a prior screening phase as producing the greatest suppression of the EL-TEP biomarker.
  • Active Comparator: Non-Personalized iTBS
    Participants receive 10 sessions of iTBS using standard fixed parameters (1800 pulses, 120% resting motor threshold).
  • Sham Comparator: Sham iTBS
    Participants receive 10 sessions of sham iTBS, matched in timing and scalp sensation to active stimulation using a shielded coil and scalp electrodes.

Primary Outcome Measure

Percent Change in Early Local TMS-Evoked Potential (EL-TEP) Amplitude [ Time Frame: Baseline, end of 10 iTBS sessions within a single testing day (10 hours) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

Find similar trials in Stanford, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Stanford University· Stanford, CA

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