Recruiting

DBS with Medtronic

Sponsor:

Helen Mayberg, MD

Code:

NCT05773755

Conditions

Major Depressive Disorder

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Not accepted

Interventions

Medtronic Percept PC DBS system

Study Details

Brief summary:

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 20 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

Major Depressive Disorder

Treatment Resistant Depression

Study ID

NCT05773755

Start date

Mar 1, 2023

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 25-70 years old.
  • Ability to provide written informed consent.
  • Primary psychiatric diagnosis of Major Depressive Disorder (MDD), either single episode or recurrent type, without psychotic features, currently experiencing a Major Depressive Episode (MDE), as diagnosed by Structured Clinical Interview for DSM IV-TR or DSM-5 (SCID-IV or SCID-5). Two independent psychiatrists will confirm the diagnosis, as well.
  • Current depressive episode of at least two years duration OR a history of more than 3 lifetime depressive episodes.
  • Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale
  • Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery)
  • A maximum Global Assessment of Functioning of 50 or less.
  • Confirmed to have treatment-resistant depression (TRD). Treatment-resistance will be defined as failure to respond to at least four adequate antidepressant treatments (assessed with the Antidepressant Treatment History Form \[ATHF-SF\] and verified through medical records) during the current episode. Treatments which support study inclusion include antidepressive medications, certain augmentation agents, evidenced-based psychotherapy, and neuromodulation (ECT, transcranial magnetic stimulation (TMS)). For those patients who have not received ECT, patients may be considered eligible for study participation if they have received adequate trials of an SSRI, SNRI, augmentation agent (certain atypical antipsychotic medications, Lithium), and TMS and/or ketamine.
  • ability comply with study and device management procedures.

Exclusion criteria:

  • Other primary Axis I conditions
  • Active suicidal ideation with intent, suicide attempt within the last six months, more than three suicide attempts within the last two years, or serious suicide risk as determined by the study psychiatrists
  • Other primary neurological disorders or unstable medical illness
  • Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required
  • Pregnancy or plan to come pregnant during the study
  • Contraindications for general anesthesia, neurosurgery, or an MRI scan
  • Currently implanted with a cardiac pacemaker / defibrillator or other implanted electrical device which may interfere with DBS stimulator or the function of which may be impacted by its implantation.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Deep Brain Stimulation (DBS) for Treatment Resistant Depression

Open label active Deep Brain Stimulation (DBS)

Interventions

Medtronic Percept PC DBS system

Open label active Deep Brain Stimulation (DBS)

Primary outcome measure

  • Change in Hamilton Depression Rating Scale (HDRS) score [ Time Frame: baseline and up to 1 year ]

Central Contacts and Locations

Central contacts

Ellie Rapp

646-493-1607ellie.rapp@mssm.edu

Zoe Schreiber

212-241-6539zoe.schreiber@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai, Mount Sinai West

Recruiting

New York, New York, United States, 10019

More Information

Sponsor

Helen Mayberg, MD

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Helen Mayberg, MD on 2026-06-22.