Imaging to Improve Brain Stimulation

NCT04016402 | Active Not Recruiting FDA Device

• 2 other identifiers: D3152-R-1N2864-C
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

This study investigates how brains change as a result of a treatment for depression called repetitive transcranial magnetic stimulation (rTMS). People who receive rTMS will have pictures of their brains and brain activity taken by a magnetic resonance imaging (MRI) scanner before and after their treatment, as well as up to three times during the six-week treatment course. These images will be examined to see if the rTMS is placed correctly to help treat their symptoms, and what changes in brain activity are happening during the rTMS treatment

Conditions

Depressive Disorder

Keywords

Transcranial Magnetic Stimulation; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Distance between treatment location and brain target

  A marker visible on MRI will be placed on the treatment location for the MRI scan after treatment completion. Functional MRI will be used to localize the dorsolateral prefrontal cortex (DLPFC), the brain region targeted by rTMS. The distance between these two points will be calculated for each participant.

  Within one week of the conclusion of clinical rTMS therapy course

Secondary Outcomes (5)

• World Health Organization Disability Assessment Schedule 2.0 36-item version

  Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course

• Inventory of Depressive Symptoms Self-Report

  Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course

• Patient Health Questionnaire 9-item

  Within one week before beginning the clinical rTMS therapy course, and weekly during the clinical rTMS therapy course (typically 6 weeks), including the last day of treatment

• Post-Traumatic Stress Disorder Checklist for DSM-5

  Within one week before beginning the clinical rTMS therapy course, and weekly during the clinical rTMS therapy course (typically 6 weeks), including the last day of treatment

• Veteran's RAND 36-item

  Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course

Other Outcomes (3)

• Functional MR imaging changes related to stimulation

  Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course

• Functional MR imaging changes predictive of outcomes

  Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course

• Functional MR imaging changes over time

  Within one week before beginning clinical rTMS therapy course, 3 times during the clinical rTMS therapy course (typically 6 weeks), and within one week after the conclusion of clinical rTMS therapy course

Study Arms (1)

Study Group

All participants enrolled in the study

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

Clinical transcranial magnetic stimulation administered as part of usual care for the study population

Also known as: transcranial magnetic stimulation, theta burst transcranial magnetic stimulation

Study Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans who receive TMS therapy for the treatment of MDD at the Providence VAMC Neuromodulation Clinic

You may qualify if:

• Veteran beginning TMS therapy for the treatment of MDD at the Providence VAMC Neuromodulation Clinic
• Age between 18 and 80 years
• Able to read, verbalize, understand, and voluntarily sign the informed consent form
• Structured Clinical Interview for DSM-5 (SCID-5) confirmed diagnosis of MDD

You may not qualify if:

• Contraindications to MRI (e.g. implanted metal or electronic devices)
• Montreal Cognitive Assessment (MoCA) score \< 26
• Pregnant

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Palo Alto Health Care System: collaborator
• Brown University: collaborator

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

Biospecimen

Retention: NONE RETAINED

None Retained

MeSH Terms

Conditions

Depressive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Allyson C Rosen, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

• Noah S. Philip, MD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: July 11, 2019
• Study Start: October 24, 2019
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)