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NCT06096207 · ClinicalTrials.gov registry record · Phase 1
DBS for Depression
A Phase 1 study of Treatment-Resistant Depression, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06096207 is a Phase 1 study of Treatment-Resistant Depression that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 20 participants, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06096207, a Phase 1 study of Treatment-Resistant Depression, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DEVICE Medtronic SenSight Directional DBS lead
Study Locations (1)
New York
- Zucker Hillside Hospital - Queens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2038-10-18 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06096207
The ClinicalTrials.gov registry entry for NCT06096207 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (95% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 1 intervention - of which Medtronic SenSight Directional DBS lead is the first listed.
NCT06096207 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06096207 about?
NCT06096207 is a clinical study titled "DBS for 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...
What is the current status of trial NCT06096207?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-10-18. Estimated completion is 2038-10-18.
What conditions does trial NCT06096207 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression.
What interventions are being tested in trial NCT06096207?
The interventions under investigation include: Medtronic SenSight Directional DBS lead (DEVICE).
Who is sponsoring clinical trial NCT06096207?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06096207 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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