Imaging to Improve Brain Stimulation

VA Office of Research and Development

Status: Active, not recruiting

Conditions: Depressive Disorder

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Observational

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

Identifiers

NCT04016402

D3152-R-1

N2864-C (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

Veteran patients can be referred to receive a Neuromodulation Clinic consult at the Providence VA Medical Center (PVAMC). Following this consultation, patients who are to begin rTMS therapy for the treatment of major depressive disorder (MDD) will be recruited to participate in this study. About 1 week prior to the scheduled beginning of rTMS therapy, research participants who provide informed consent will complete baseline neuropsychological measures. Within a few days of completing these measures, and before beginning rTMS therapy, participants will receive an MRI scan, including structural and functional imaging. Participants will have a similar set of MRI scans up to three times during the course of rTMS therapy, and complete neuropsychological measures at these scanning sessions. A final MRI scan will be conducted within a week of completing the rTMS therapy course, and neuropsychological measures will be completed at this session.

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

42 participants in 1 patient group

Study Group

Description:

All participants enrolled in the study

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)