Imaging Biomarkers for TMS Treatment of Depression
2 other identifiers
interventional
40
1 country
1
Brief Summary
The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment. The study will use functional magnetic resonance imaging (fMRI) to examine changes in brain function after treatment with rTMS. fMRI is a safe and painless technique that allows investigators to observe the brain "at work." The investigators will use fMRI to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rTMS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Sep 2013
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
April 25, 2017
CompletedApril 25, 2017
April 1, 2017
2.3 years
July 11, 2013
January 9, 2017
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depressive Symptoms at 4 Weeks
MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
4 weeks after baseline
Secondary Outcomes (1)
Depression Symptoms at 4 Weeks- Secondary
4 weeks after baseline
Study Arms (2)
Active rTMS
ACTIVE COMPARATOR20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.
Sham rTMS
SHAM COMPARATOR20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.
Interventions
20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.
Eligibility Criteria
You may qualify if:
- Primary diagnosis of major depressive disorder
- Male and female subjects, ages 22-65
- Have failed at least 1 antidepressant medication at adequate dose and duration
- On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy
You may not qualify if:
- Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder
- Active substance abuse, including alcohol
- Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury;
- No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body;
- Pregnant or trying to get pregnant
- Failed to respond to an adequate course of electroconvulsive therapy (ECT)
- Previous treatment with TMS
- Current depressive episode longer than 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute of Mental Health (NIMH)collaborator
- Neuroneticscollaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Taylor SF, Ho SS, Abagis T, Angstadt M, Maixner DF, Welsh RC, Hernandez-Garcia L. Changes in brain connectivity during a sham-controlled, transcranial magnetic stimulation trial for depression. J Affect Disord. 2018 May;232:143-151. doi: 10.1016/j.jad.2018.02.019. Epub 2018 Feb 21.
PMID: 29494898DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small size, not powered for group differences. Primary measure was not clinical, but brain changes (primary measures for this report have only focused on clinical changes as neural changes cannot be entered into this reporting format
Results Point of Contact
- Title
- Stephan Taylor
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan F Taylor, MD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
July 11, 2013
First Posted
July 16, 2013
Study Start
September 1, 2013
Primary Completion
January 1, 2016
Study Completion
April 1, 2016
Last Updated
April 25, 2017
Results First Posted
April 25, 2017
Record last verified: 2017-04