Targeting Functional Improvement in rTMS Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Disorder
- Sponsor
- VA Office of Research and Development
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Distance between treatment location and brain target
- Status
- Active, not recruiting
- Last Updated
- 12 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Distance between treatment location and brain target
Time Frame: 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 Outcomes
- 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)