Sensory Synchronized Imaging and Neuromodulation

NCT ID: NCT06548113

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2029-10-01

Brief Summary

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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

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard 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.

Group Type ACTIVE_COMPARATOR

TMS

Intervention Type DEVICE

transcranial magnetic brain stimulation

Sensory-entrained TMS (seTMS)

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.

Group Type ACTIVE_COMPARATOR

TMS

Intervention Type DEVICE

transcranial magnetic brain stimulation

Interventions

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TMS

transcranial magnetic brain stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica M Ross, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

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VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica M Ross, PhD

Role: CONTACT

(530) 902-2450

Facility Contacts

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Jessica M Ross, PhD

Role: primary

530-902-2450

Other Identifiers

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76106

Identifier Type: OTHER

Identifier Source: secondary_id

MHBC-011-24F

Identifier Type: -

Identifier Source: org_study_id

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