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Clinical Trials/NCT06548113
NCT06548113
Recruiting
Not Applicable

Investigation of Sensory Synchronized Human Brain Imaging and Neuromodulation

VA Office of Research and Development1 site in 1 country250 target enrollmentApril 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
VA Office of Research and Development
Enrollment
250
Locations
1
Primary Endpoint
Transcranial Magnetic Stimulation (TMS) / Electroencephalography (EEG) change
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 1, 2025
End Date
October 1, 2029
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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).

Study Sites (1)

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