Imaging to Improve Brain Stimulation
- Conditions
- Depressive Disorder
- Interventions
- Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
- Registration Number
- NCT04016402
- Lead Sponsor
- VA Office of Research and Development
- 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
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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
- Contraindications to MRI (e.g. implanted metal or electronic devices)
- Montreal Cognitive Assessment (MoCA) score < 26
- Pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Group Repetitive Transcranial Magnetic Stimulation (rTMS) All participants enrolled in the study
- Primary Outcome Measures
Name Time Method Distance between treatment location and brain target Within one week of the conclusion of clinical rTMS therapy course 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.
- Secondary Outcome Measures
Name Time Method 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 Scores from the World Health Organization Disability Assessment Schedule 36-item version (WHODAS-36). Self-assessment of global functioning, with scores ranging from 0 (no disability) to 100 (full disability).
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 Scores from the Inventory of Depressive Symptoms Self-Report (IDS-SR). A 30-item self-assessment of depressive symptoms with scores ranging from 0 (no depressive symptoms) to 90 (severe depression).
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 Scores from the Patient Health Questionnaire, 9-item version (PHQ-9). A self-assessment of depressive symptoms with scores ranging from 0 (no depressive symptoms) to 27 (severe depression).
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 Scores from the Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5). A self-assessment of PTSD symptoms with scores ranging from 0 (no PTSD symptoms) to 80 (severe PTSD symptoms)
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 Scores from the Veteran's RAND 36-item (VR-36). Assessment of self-reported health quality of life. Includes physical and mental component normed subscores (x=50, sd=10) ranging from 0 (worst health) to 100 (best health).
Trial Locations
- Locations (2)
Providence VA Medical Center, Providence, RI
🇺🇸Providence, Rhode Island, United States
VA Palo Alto Health Care System, Palo Alto, CA
🇺🇸Palo Alto, California, United States