Actively Recruiting
DBS for TRD With the Medtronic Percept PC
Led by Helen Mayberg, MD · Updated on 2026-02-12
10
Participants Needed
1
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Of the estimated 30 million Americans who suffer from Major Depressive Disorder, approximately 10% are considered treatment resistant. Deep brain stimulation (DBS) to a region of the brain called the subcallosal cingulate (SCC) is an emerging strategy for treatment resistant depression (TRD), which involves placement of electrodes in a specific region of the brain and stimulating that area with electricity. This is believed to reset the brain network responsible for symptoms and results in a significant antidepressant response. A series of open-label studies have demonstrated sustained, long-term antidepressant effects in 40-60% of patients who received this treatment. A challenge to the effective dissemination of this fledgling treatment is the absence of biomarkers (objective, measureable indications of the state of the body and brain) to guide device placement and select stimulation parameters during follow-up care. By using a DBS device called the Percept PC (Medtronic, Inc) which has the ability to both deliver stimulation to and record electrical signals directly from the brain, this study aims to identify changes in local field potentials (LFPs), specific electrical signals that are thought to represent how the brain communicates information from one region to another, to see how this relates to DBS parameter settings and patient depressive symptomatology. The goal of this study is to study LFPs before and during active DBS stimulation to identify changes that correlate with the antidepressant effects of SCC DBS. The study team will recruit 10 patients with TRD and implant them with the Percept PC system. Participants will be asked to complete short questionnaires and collect LFP data twice daily for the first year of the study, as well as have weekly in person research procedures and assessments with the study team for up to one year. These include meetings with the study psychiatrist, psychologist, symptom ratings, and movement, voice, and video recordings. A brief discontinuation experiment will be conducted after 6 months of stimulation, in which the stimulation will be turned off and patterns of LFP changes will be recorded. The entire study is expected to last about 5 years, parcellated into several study phases. All participants are required to live in the New York metropolitan area for the first several months of the study.
CONDITIONS
Official Title
DBS for TRD With the Medtronic Percept PC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 25-70 years old.
- Ability to provide written informed consent.
- Primary diagnosis of Major Depressive Disorder, currently experiencing a Major Depressive Episode.
- Current depressive episode lasting at least two years or history of more than three lifetime depressive episodes.
- Minimum score of 20 on the 17-item Hamilton Depression Rating Scale at study entry.
- Average pre-operative HDRS-17 score of 20 or greater over four weekly pre-surgical evaluations.
- Global Assessment of Functioning score of 50 or less.
- Confirmed treatment-resistant depression defined as failure to respond to at least four adequate antidepressant treatments during the current episode.
- Ability to comply with study and device management procedures.
You will not qualify if you...
- Other primary Axis I psychiatric conditions.
- Active suicidal ideation with intent, suicide attempt within last six months, more than three attempts in last two years, or serious suicide risk.
- Other primary neurological disorders or unstable medical illnesses.
- Conditions requiring anticoagulant therapy that cannot be stopped for surgery.
- Pregnancy or planning pregnancy during the study.
- Contraindications for general anesthesia, neurosurgery, or MRI.
- Presence of implanted cardiac pacemaker, defibrillator, or other electrical devices that may interfere with DBS or be affected by its implantation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai, Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
Research Team
I
Isha Trivedi
CONTACT
Z
Zoe Schreiber
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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