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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06096207). This is a study registration, not published results. Lead sponsor: Northwell Health. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Treatment Resistant Depression. Interventions: DEVICE: Medtronic SenSight Directional DBS lead. Primary outcome measures: Montgomery-Asberg Depression Rating Scale (MADRS) , 12 months. Brief summary: 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.