DBS for TRD With the Medtronic Summit RC+S
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|ClinicalTrials.gov Identifier: NCT04106466|
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : September 27, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Treatment Resistant Depression||Device: Medtronic Summit RC+S DBS system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will be implanted with the study device and receive open label, active DBS stimulation|
|Masking:||None (Open Label)|
|Masking Description:||N/A. This is open label study.|
|Primary Purpose:||Basic Science|
|Official Title:||Deep Brain Stimulation (DBS) for Treatment Resistant Depression: Exploration of Local Field Potentials (LFPs) With the Medtronic Summit RC+S "Brain Radio" System|
|Actual Study Start Date :||January 21, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2030|
Experimental: Deep Brain Stimulation (DBS)
Open label active Deep Brain Stimulation (DBS)
Device: Medtronic Summit RC+S DBS system
Open label active Deep Brain Stimulation (DBS)
- Change in Hamilton Depression Rating Scale (HDRS) score [ Time Frame: Baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation ]Change in Hamilton Depression Rating Scale (HDRS) score at 6 months and 1 year of continuous active stimulation as compared to preoperative baseline. The score for Hamilton Depression Rating Scale, 17 item version, full range from 0-50, with a higher score indicating more severe depression.
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation ]Change in Montgomery-Asberg Depression Rating Scale (MADRS) after 6 months and 1 year of continuous active stimulation compared to baseline. MADRS items are rated on a 0 to 6 continuum (0 = no abnormality, 6 = severe). Total score range from 0 to 60, with higher total scores indicating increased severity of depressive symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106466
|Contact: Jaimie L Gowatsky, MAemail@example.com|
|Contact: Emma Meyerfirstname.lastname@example.org|
|United States, New York|
|Icahn School of Medicine at Mount Sinai, Mount Sinai West||Recruiting|
|New York, New York, United States, 10019|
|Principal Investigator:||Helen Mayberg, MD||Icahn School of Medicine at Mount Sinai|