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Imaging to Improve Brain Stimulation

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ClinicalTrials.gov Identifier: NCT04016402
Recruitment Status : Enrolling by invitation
First Posted : July 11, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
VA Palo Alto Health Care System
Brown University
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Depressive Disorder Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Targeting Functional Improvement in rTMS Therapy
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study Group
All participants enrolled in the study
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Clinical transcranial magnetic stimulation administered as part of usual care for the study population
Other Name: transcranial magnetic stimulation, theta burst transcranial magnetic stimulation




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. World Health Organization Disability Assessment Schedule 2.0 36-item version [ Time Frame: 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).

  2. Inventory of Depressive Symptoms Self-Report [ Time Frame: 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).

  3. Patient Health Questionnaire 9-item [ Time Frame: 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).

  4. Post-Traumatic Stress Disorder Checklist for DSM-5 [ Time Frame: 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)

  5. Veteran's RAND 36-item [ Time Frame: 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).


Other Outcome Measures:
  1. Functional MR imaging changes related to stimulation [ Time Frame: 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 ]
    Magnetic resonance imaging acquired throughout TMS will be analyzed to evaluate aggregate changes related to stimulation

  2. Functional MR imaging changes predictive of outcomes [ Time Frame: 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 ]
    Magnetic resonance imaging acquired throughout TMS will be analyzed to evaluate how brain changes can be used to predict outcomes

  3. Functional MR imaging changes over time [ Time Frame: 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 ]
    Magnetic resonance imaging acquired throughout TMS will be analyzed to evaluate how MR imaging of an individual changes over time


Biospecimen Retention:   None Retained
None Retained


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Veterans who receive TMS therapy for the treatment of MDD at the Providence VAMC Neuromodulation Clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016402


Locations
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United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
VA Office of Research and Development
VA Palo Alto Health Care System
Brown University
Investigators
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Principal Investigator: Noah S. Philip, MD Providence VA Medical Center, Providence, RI
Principal Investigator: Allyson C Rosen, PhD VA Palo Alto Health Care System, Palo Alto, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04016402     History of Changes
Other Study ID Numbers: D3152-R-1
N2864-C ( Other Grant/Funding Number: Center for Neurorestoration and Neurotechnology )
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Transcranial Magnetic Stimulation
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Depressive Disorder
Mood Disorders
Mental Disorders