Investigating the Neural Mechanisms of Repetitive Brain Stimulation With Invasive and Noninvasive Electrophysiology in Humans

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05996900
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Intracranial electrodes — DEVICE
    Intracranial electrodes will be used for the delivery of invasive brain stimulation.
  • TMS — DEVICE
    TMS will be used for the delivery of noninvasive brain stimulation both before and after implantation electrode surgery.

Study Details

Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but clinical outcome is suboptimal, partially because investigators are missing biologically-grounded brain markers which show that TMS is modifying activity at the intended target in the brain. The goal of this proposal is to characterize the key markers of the brain's response to repeated doses of TMS with high resolution using invasive brain recordings in humans, and relate these brain markers to noninvasive recordings. These markers will improve the understanding of TMS and can be used to optimize and enhance clinical efficacy for depression and other psychiatric disorders.

Key Dates

Start date
Sep 1, 2023
Status verified
Mar 2026
Primary completion
Oct 1, 2027
Completion
Dec 1, 2027

Study Design

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

Arms

  • Active Comparator: TBS via direct electrical stimulation
  • Active Comparator: TBS via transcranial magnetic stimulation
  • Sham Comparator: Sham TBS via direct electrical stimulation
  • Sham Comparator: Sham TBS via transcranial magnetic stimulation

Primary Outcome Measure

TMS-iEEG change after one TBS session [ Time Frame: 45 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305

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