Status:
UNKNOWN
Machine Learning to Predict Clinical Response to TMS
Lead Sponsor:
Brown University
Collaborating Sponsors:
Providence VA Medical Center
Conditions:
Depression, Unipolar
Eligibility:
All Genders
18-65 years
Brief Summary
Major Depressive Disorder (MDD) is a common and debilitating illness. It affects a person's family and personal relationships, work, education, and life. It changes sleeping and eating habits and sign...
Eligibility Criteria
Inclusion
- diagnosis of MDD, assessed by the Structured Clinical Interview of DSM-5 (SCID)
- treatment-resistant, operationally defined as failure to achieve clinical remission (MADRS \<7) remit following at least one antidepressant trial in the current major depressive episode.
- Symptoms must be of at least moderate severity (MADRS score \>19)
- medications will be stable for at least six weeks prior to TMS, and there will be no dose changes unless medically necessary
Exclusion
- \* Standard contraindications to TMS and EEG :
- metal in the head and neck
- history of serious head injury or loss of consciousness over 10 minutes
- dementia
- seizure history
- other serious neurological disorders
- serious or unstable medical conditions that would affect EEG signal
- current severe substance use disorders (except for nicotine or caffeine)
- bipolar or psychotic-spectrum disorders (e.g., schizophrenia, schizoaffective disorder, etc.)
- Prior non-responders to TMS will also be excluded.
Key Trial Info
Start Date :
October 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 18 2020
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03847688
Start Date
October 22 2018
End Date
September 18 2020
Last Update
February 25 2019
Active Locations (1)
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1
Providence VA Medical Center
Providence, Rhode Island, United States, 02908