Imaging to Improve Brain Stimulation

Depressive Disorder Clinical Trial

Official title:

Targeting Functional Improvement in rTMS Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04016402
• Other study ID #: D3152-R-1
• Secondary ID: N2864-C
• Status: Active, not recruiting
• Start date: October 24, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (rTMS)
Clinical transcranial magnetic stimulation administered as part of usual care for the study population

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Brown University, VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional MR imaging changes related to stimulation	Magnetic resonance imaging acquired throughout TMS will be analyzed to evaluate aggregate 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
Other	Functional MR imaging changes predictive of outcomes	Magnetic resonance imaging acquired throughout TMS will be analyzed to evaluate how brain changes can be used to predict 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
Other	Functional MR imaging changes over time	Magnetic resonance imaging acquired throughout TMS will be analyzed to evaluate how MR imaging of an individual 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
Primary	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	World Health Organization Disability Assessment Schedule 2.0 36-item version	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).	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
Secondary	Inventory of Depressive Symptoms Self-Report	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).	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
Secondary	Patient Health Questionnaire 9-item	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).	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
Secondary	Post-Traumatic Stress Disorder Checklist for DSM-5	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)	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
Secondary	Veteran's RAND 36-item	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).	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