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Neural Circuit Biomarkers of Transcranial Magnetic Stimulation Study
Recruiting
I'm InterestedTrial ID: NCT04663841
Purpose
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)
Eligibility
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
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
Intervention(s):
other: transcranial magnetic stimulation
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Leanne Williams, PhD
650-723-3579