Recruiting

TMS

Sponsor:

Stanford University

Code:

NCT05996900

Conditions

Major Depressive Disorder

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Intracranial electrodes

TMS

Study Details

Brief summary:

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.

Conditions

Major Depressive Disorder

Epilepsy

Study ID

NCT05996900

Start date

Sep 1, 2023

Status verified date

Mar, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and women, ages 18 to 65
  • Medication-refractory epilepsy requiring phase II monitoring
  • Must have intellectual capacity to ensure adequate comprehension of the study and potential risks involved in order to provide informed consent
  • No current or history of major neurological disorders other than epilepsy

Exclusion Criteria:

  • Those with a contraindication for MRIs (e.g. implanted metal)
  • Any unstable medical condition
  • Neurological or uncontrolled medical disease
  • Active substance abuse
  • Currently pregnant or breastfeeding

Study Design

Enrollment

49 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

Intracranial electrodes

Intracranial electrodes will be used for the delivery of invasive brain stimulation.

TMS

TMS will be used for the delivery of noninvasive brain stimulation both before and after implantation electrode surgery.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jade Truong

(408) 840-3313kellerlab@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Jade Truong

kellerlab@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-03-12.