Sensory Synchronized Imaging and Neuromodulation

NCT06548113 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: MHBC-011-24F76106
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to better understand the relationship between the type of brain stimulation used and how it changes brain activity in adult military Veterans. The goal is to use this understanding to develop new, personalized brain stimulation. The investigators evaluate brain changes from different types of transcranial magnetic brain stimulation (TMS).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Transcranial Magnetic Stimulation (TMS) / Electroencephalography (EEG) change

  Change in the TMS-EEG measure will be assessed before, during, and after each TMS session. Specifically, the difference in size of the evoked response after a single TMS pulse in the frontoparietal region will be quantified in microVolts and compared between standard TMS and sensory-entrained TMS (se-TMS).

  45 minutes

Study Arms (2)

Standard TMS

ACTIVE COMPARATOR

A series of standard TMS protocols will be delivered to determine target engagement compared to seTMS. TMS will be delivered using neuro-navigation based on participant's own MRI images. Intensity will be set to 120% of the participant's motor threshold. Participants will be monitored during the session for adverse events and/or side effects.

Device: TMS

Sensory-entrained TMS (seTMS)

ACTIVE COMPARATOR

Sensory entrained TMS (seTMS) is a combination of music and TMS to align brain oscillations and enhance the effects of TMS. seTMS will be delivered to determine target engagement to noninvasive seTMS brain stimulation compared to standard TMS. TMS will be delivered using neuro-navigation based on participant's own MRI images. Intensity will be set to 120% of the participant's motor threshold. Participants will be monitored during the session for adverse events and/or side effects.

Device: TMS

Interventions

TMS DEVICE

transcranial magnetic brain stimulation

Sensory-entrained TMS (seTMS); Standard TMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, ages 18 years and up
• English speaking
• Military Veterans

You may not qualify if:

• Those with a contraindication for MRIs (e.g. implanted metal)
• History of head trauma with loss of consciousness
• History of seizures or on medications that substantially reduce seizure threshold
• Neurological or uncontrolled medical disease
• Active substance abuse
• Currently pregnant or breastfeeding

Sponsors & Collaborators

• VA Office of Research and Development: lead
• National Institute of Mental Health (NIMH): collaborator
• Stanford University: collaborator

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Jessica M Ross, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica M Ross, PhD

CONTACT

(530) 902-2450; jessica.ross1@va.gov

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: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 12, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)