NCT04106466

DBS for TRD With the Medtronic Summit RC+S

Active, enrolled NA Last updated 17 February 2026

What this trial tests

NA trial testing Medtronic Summit RC+S DBS system in Major Depressive Disorder in 10 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 January 2020

Primary endpoint
31 December 2030

31 December 2030

Quick facts

Lead sponsor	Helen Mayberg, MD
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	10
Start date	21 January 2020
Primary completion	31 December 2030
Estimated completion	31 December 2030
Sites	1 location across United States

Drugs / interventions tested

• Medtronic Summit RC+S DBS system

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →
• Treatment Resistant Depression — all drugs for Treatment Resistant Depression →

Sponsor

Helen Mayberg, MD

Who can join

Adults 25 to 70, any sex, with Major Depressive Disorder or Treatment Resistant Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 an experimental prototype DBS device called the Summit RC+S (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 Summit RC+S 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 periodic EEGs (scalp brainwave recordings). A brief discontinuation experiment will be conducted after 6 months of stimulation, in which the device will be turned off and patterns of LFP changes will be recorded. The entire study is expected to last about 10 years, which is the expected life of the battery that powers the device. All participants are required to live in the New York metropolitan area for the first two years of the study.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Analysis-rcs-data: Open-Source Toolbox for the Ingestion, Time-Alignment, and Visualization of Sense and Stimulation Data From the Medtronic Summit RC+S System.
   Sellers KK, Gilron R, Anso J, Louie KH, et al · · 2021 · cited 41× · PMID 34322004 · DOI 10.3389/fnhum.2021.714256
2. Advances in Deep Brain Stimulation: From Mechanisms to Applications.
   Sandoval-Pistorius SS, Hacker ML, Waters AC, Wang J, et al · · 2023 · cited 21× · PMID 37940596 · DOI 10.1523/jneurosci.1427-23.2023
3. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
4. Invasive Electrophysiology for Circuit Discovery and Study of Comorbid Psychiatric Disorders in Patients With Epilepsy: Challenges, Opportunities, and Novel Technologies.
   Balzekas I, Sladky V, Nejedly P, Brinkmann BH, et al · · 2021 · cited 16× · PMID 34381344 · DOI 10.3389/fnhum.2021.702605
5. Best practices for clinical trials of deep brain stimulation for neuropsychiatric indications.
   Tremblay-McGaw AG, Hamlat EJ, Becker NC, Astudillo Maya DA, et al · · 2025 · cited 1× · PMID 40309667 · DOI 10.3389/fnhum.2025.1572972