Neural Circuit Biomarkers of Transcranial Magnetic Stimulation Study


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Trial ID: NCT04663841


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 prospectively replicated in a large ecologically valid sample. We focus on cognitive network connectivity as a predictive biomarker of the clinical effect of TMS, and as a response biomarker of change with TMS. We address this objective through a pragmatic approach in which we recruit patients undergoing routine clinical care and program evaluation in a Veterans Administration multi-site clinical TMS program.

Official Title

Mechanistic Circuit Markers of Transcranial Magnetic Stimulation Outcomes in Pharmacoresistant Depression

Stanford Investigator(s)


Inclusion Criteria:

   - 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 Criteria:

   - History of seizure disorder

   - Structural or neurologic abnormalities present or in close proximity to the treatment

   - 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

   - 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


other: transcranial magnetic stimulation


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Leanne Williams, PhD