Treatment Resistant Depression Clinical Trial
Official title:
Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression
The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are: - Is deep brain stimulation effective in treating treatment resistant depression? - Does deep brain stimulation improve overall clinical well-being and functioning? Participants will be implanted with a deep brain stimulation device. They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms. The device will be turned off at certain time points, unbeknown to the participant, to show the efficacy of the device when it is turned on. The device will be ON for 8.5 months and OFF for 3.5 months during the first year. Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression.
This initial study at Northwell Health has the purpose to demonstrate the feasibility and safety of performing slMFB DBS as a treatment for TRD at Northwell Health as well as more clearly establish efficacy. The investigators hypothesize that DBS targeting can be consistently placed in the supero-lateral branch of the medial forebrain bundle (slMFB) after identification using diffusion tensor imaging and fiber tract analysis, as performed in DBS at UTHealth. The investigators will implant the Medtronic SenSight Directional DBS lead at this target location. ;
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