Sensory Synchronized Imaging and Neuromodulation

VA Office of Research and Development

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Device: TMS

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT06548113

MHBC-011-24F

76106

Details and patient eligibility

About

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).

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Standard TMS

Active Comparator group

Description:

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.

Treatment:

Device: TMS

Sensory-entrained TMS (seTMS)

Active Comparator group

Description:

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.

Treatment:

Device: TMS