Neural Circuit Biomarkers of Transcranial Magnetic Stimulation Study
Trial ID or NCT#
Status
RECRUITING
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
Eligibility 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
- - 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Leanne Williams, PhD
650-723-3579
View on ClinicalTrials.gov
