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DBS for Depression

NCT06096207 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Northwell Health

    lead OTHER

Principal Investigators

  • Albert J Fenoy, MD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2030-10-18
Completion
2038-10-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06096207 on ClinicalTrials.gov