DBS for TRD With the Medtronic Summit RC+S

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 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.

Conditions

• Major Depressive Disorder
• Treatment Resistant Depression

Interventions

DEVICE

Medtronic Summit RC+S DBS system

Open label active Deep Brain Stimulation (DBS)

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• Georgia Institute of Technology

  collaborator OTHER

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Helen Mayberg, MD

  lead OTHER

Principal Investigators

• Helen Mayberg, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-21

Primary Completion

2030-12-31

Completion

2030-12-31

FDA Device

Yes

Countries

• United States

Study Locations