Status:
ACTIVE_NOT_RECRUITING
Neural Circuit Biomarkers of Transcranial Magnetic Stimulation Study
Lead Sponsor:
Stanford University
Collaborating Sponsors:
VA Palo Alto Health Care System
Florida State University
Conditions:
Depression
Eligibility:
All Genders
18+ years
Brief Summary
This study is currently recruiting Veterans only. The objective of this observational study is to test whether neuroimaging biomarkers of repetitive transcranial magnetic stimulation (TMS) can be pros...
Detailed Description
Although repetitive transcranial magnetic stimulation (TMS) is becoming a gold standard treatment for pharmacoresistant depression, we lack neural target biomarkers for identifying who is most likely ...
Eligibility Criteria
Inclusion
- Ages 18 years and older
- Meets Diagnostic and Statistical Manual edition 5 (DSM-5) criteria for Major Depressive Disorder (MDD) (as documented by the treating physician)
- Meet study criteria for pharmacoresistance in accordance with the Clinical transcranial magnetic stimulation (TMS) Program (i.e. failed at least one antidepressant in the current episode)
- Ability to obtain a motor threshold (MT) prior to the start of treatment
- Stable medical conditions and ability to maintain stability on current medication regimen for the duration of treatment
- Ability to participate in a daily treatment regimen
- Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments
Exclusion
- History of seizure disorder
- Structural or neurologic abnormalities present or in close proximity to the treatment site
- History of brain surgery
- Pacemaker or medical infusion device (unless magnetic resonance imaging compatible)
- History of traumatic brain injury within 60 days of the start of treatment
- Severe or uncontrolled alcohol or substance use disorders
- Active withdrawal from alcohol or substances
- Implanted device in the head
- Metal in the head
- Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments, or unable and/or unlikely to follow the study protocols
- Lifetime history of bipolar I disorder
- Inability to speak, read or understand English
- Plans to move out of the area during the study period
- Clinician and/or Investigator discretion for clinical safety or protocol adherence
Key Trial Info
Start Date :
November 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04663841
Start Date
November 2 2020
End Date
May 31 2026
Last Update
January 5 2026
Active Locations (1)
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1
Stanford University Department of Psychiatry
Stanford, California, United States, 94305