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

NCT05996900 | Recruiting DMC FDA Device

• 2 other identifiers: 11354-11R01MH132074
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• TMS-iEEG change after one TBS session

  Change in evoked response measured after a single TBS session for active and sham, by resting state iEEG (intracranial EEG) and/or sEEG (stereo EEG).

  45 minutes

Secondary Outcomes (3)

• ES-iEEG change after one TBS session

  45 minutes

• ES-iEEG change between two sequential TBS sessions

  45 minutes

• TMS-iEEG change between two sequential TBS sessions

  45 minutes

Study Arms (4)

TBS via direct electrical stimulation

ACTIVE COMPARATOR

Device: Intracranial electrodes

TBS via transcranial magnetic stimulation

ACTIVE COMPARATOR

Device: TMS

Sham TBS via direct electrical stimulation

SHAM COMPARATOR

Device: Intracranial electrodes

Sham TBS via transcranial magnetic stimulation

SHAM COMPARATOR

Device: TMS

Interventions

Intracranial electrodes DEVICE

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

Sham TBS via direct electrical stimulation; TBS via direct electrical stimulation

TMS DEVICE

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

Sham TBS via transcranial magnetic stimulation; TBS via transcranial magnetic stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• University of Iowa: collaborator
• Massachusetts General Hospital: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Epilepsy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jade Truong

CONTACT

(408) 840-3313; kellerlab@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 18, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)