DBS for Depression

Part of paid clinical trials in Queens, New York.

Sponsor
Northwell Health
Study ID
NCT06096207
Phase
PHASE1
Status
Recruiting
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Conditions

  • Treatment Resistant Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Medtronic SenSight Directional DBS lead — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 18, 2023
Status verified
Jun 2026
Primary completion
Oct 18, 2030
Completion
Oct 18, 2038

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Discontinuation Phase Group 1
    Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.
  • Experimental: Discontinuation Phase Group 2
    Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks.

Primary Outcome Measure

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zucker Hillside HospitalQueensNew York11004
Samantha Gonzalez
[email protected]
718-470-4152
Albert J Fenoy, MD (PRINCIPAL_INVESTIGATOR)
Miklos Argyelan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Queens, NY

By research site
Zucker Hillside Hospital· Queens, NY

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