NCT06096207

DBS for Depression

Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DEVICE	Medtronic SenSight Directional DBS lead	At the ninth month post DBS implantation, the participant will enter a discontinuation phase of a duration of 6 weeks. The device will be turned on and off without participants' knowledge. After 6 weeks, the device will be turned back on if it was off. Whether the stimulation is active or not, it will be double blinded.

Timeline

• Start date: 2023-10-18
• Primary completion: 2030-10-18
• Completion: 2038-10-18
• First posted: 2023-10-23
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study