Sensory Synchronized Imaging and Neuromodulation

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder
• Interventions: Device: TMS

• Registration Number: NCT06548113
• Lead Sponsor: VA Office of Research and Development

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-12
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2029-10-01
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sensory-entrained TMS (seTMS)	TMS	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.
Standard TMS	TMS	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.

Primary Outcome Measures

Name	Time	Method
Transcranial Magnetic Stimulation (TMS) / Electroencephalography (EEG) change	45 minutes	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).

Trial Locations

Locations (1)

VA Palo Alto Health Care System, Palo Alto, CA; 🇺🇸 Palo Alto, California, United States