Brain-Based Biomarkers in Response to TMS in MDD
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|ClinicalTrials.gov Identifier: NCT02843373|
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : February 28, 2020
|Condition or disease||Intervention/treatment|
|Major Depressive Disorder Depression||Device: TMS|
Goals of the study are as follows:
- To evaluate the ability to predict and track brain network changes during TMS treatment for medication-resistant depression.
- To develop quantitative tools that measure the connectivity and excitability of the brain using resting and single pulse TMS-EEG.
- To determine the feasibility of recording EEG biomarkers in the clinic without disrupting clinical care.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Longitudinal, Prospective Study to Examine the Brain-based Biomarkers of Response to Transcranial Magnetic Stimulation Treatment in Major Depressive Disorder|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||December 2022|
rTMS will be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS will be delivered to the left DLPFC as assessed by either the 5cm rule or F3 site. Daily treatment regiments will last 36.5 minutes and rTMS will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS sessions for adverse events and/or side effects.
- TMS-EEG [ Time Frame: Up to 3 months ]From pre- to post-treatment, improvement will be based on enhanced excitability and connectivity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843373
|Contact: Corey Keller, MD PhDemail@example.com|
|United States, California|
|Palo Alto, California, United States, 94304|
|Contact: Corey Keller, MD PhD firstname.lastname@example.org|
|Principal Investigator: Amit Etkin, MD PhD|
|Principal Investigator:||Amit Etkin, MD PhD||Stanford University|