Clinical trial NCT04016402: Imaging to Improve Brain Stimulation
Official title: Targeting Functional Improvement in rTMS Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Depressive Disorder
Keywords: Transcranial Magnetic Stimulation
Magnetic Resonance Imaging
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Palo Alto Health Care System
name: Brown University
First posted: 2019-07-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans who receive TMS therapy for the treatment of MDD at the Providence VAMC Neuromodulation Clinic

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.

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
* Pregnant

Primary outcomes:
measure: Distance between treatment location and brain target
timeFrame: Within one week of the conclusion of clinical rTMS therapy course
Secondary outcomes:
measure: World Health Organization Disability Assessment Schedule 2.0 36-item version
timeFrame: 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
measure: Inventory of Depressive Symptoms Self-Report
timeFrame: 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
measure: Patient Health Questionnaire 9-item
timeFrame: 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
measure: Post-Traumatic Stress Disorder Checklist for DSM-5
timeFrame: 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
measure: Veteran's RAND 36-item
timeFrame: 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:
measure: Functional MR imaging changes related to stimulation
timeFrame: 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
measure: Functional MR imaging changes predictive of outcomes
timeFrame: 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
measure: Functional MR imaging changes over time
timeFrame: 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
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Allyson C Rosen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence VA Medical Center, Providence, RI
name: Noah S. Philip, MD
role: PRINCIPAL_INVESTIGATOR
References: