Major Depressive DisorderNCT04106466
DBS for TRD With the Medtronic Summit RC+S
A study testing Medtronic Summit RC+S DBS system in people with Major Depressive Disorder and Treatment Resistant Depression, run by Helen Mayberg, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Treatment Resistant Depression
- What is being tested?
- Medtronic Summit RC+S DBS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25-70 years old.
- Ability to provide written informed consent.
- Lives within commuting distance to New York City and study location (Mount Sinai West Hospital)
- 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 (SCID). Two independent psychiatrists will confirm the diagnosis.
- 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 (HDRS-17)
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- Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery) and an average pre-operative HDRS-17 score no more than 30% lower than the baseline screening HDRS-17 score.
- 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 a minimum of four different antidepressant treatments (including at least three medications from at least three different drug classes), evidence-based psychotherapy, or electroconvulsive therapy (ECT) administered at adequate doses and duration during the current episode. We will require documentation (i.e., statement from the treating psychiatrist) that a treatment trial has failed (either no response to maximum tolerable doses for a minimum of 4 weeks, or side effects at sub-maximal doses) as coded by a revised Antidepressant Treatment History Form (ATHF). The study investigators will confirm each treatment via review of records from referring psychiatrists and/or pharmacy records.
- Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode (confirmed by medical records) or not receiving ECT due to a reason considered valid by the study psychiatrist. Such reasons might include lack of availability of ECT providers in the patient's location, concern regarding the impact of cognitive side effects of ECT on current ability to work or function, or inability to obtain third-party payment for ECT. Additionally, it is recognized that the probability that a patient who has failed four medications in the current episode will achieve a lasting response with ECT is about 18% (60% probability of an acute response and 30% of maintaining response for at least 24 weeks); patients who have refused ECT because they feel the chance of benefit does not outweigh the risks associated with ECT will be considered eligible.
- Able to undergo preoperative MRI
- Have a designated caregiver available to assist in compliance with study procedures
- Willing and able to comply with all study-related appointments and procedures
Who cannot join
- Other Axis I comorbid 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
- Conditions requiring MRI scans or diathermy
- Pregnancy or plan to come pregnant during the study
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- 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.
- Patients who lack the capacity for proper device usage and maintenance, in the opinion of the research team
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai, Mount Sinai West
New York, New York, 10019
About this study
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
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.
- Being tested
- Medtronic Summit RC+S DBS system
- Keywords
- Deep Brain Stimulation, Major Depressive Disorder, Treatment resistant depression, subcallosal cingulate white matter, Depression
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Summit RC+S DBS systemDevice
Open label active Deep Brain Stimulation (DBS)
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation (DBS) | Experimental | Open label active Deep Brain Stimulation (DBS) Receives: Device: Medtronic Summit RC+S DBS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale (HDRS) score
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.
Measured: Baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation
Secondary outcomes (1)
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Measured: Baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start21 Jan 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be implanted with the study device and receive open label, active DBS stimulation
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helen Mayberg, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, Georgia Institute of Technology, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Helen Mayberg, MD, Icahn School of Medicine at Mount Sinai
- Investigators
- Helen Mayberg, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106466
- Sponsor's protocol ID
- GCO 17-2763
- Other IDs
- 5UH3NS103550
- Status last verified
- Jun 2026
- First submitted
- 25 Sep 2019
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Riva-Posse P, Choi KS, Holtzheimer PE, Crowell AL, Garlow SJ, Rajendra JK, McIntyre CC, Gross RE, Mayberg HS. A connectomic approach for subcallosal cingulate deep brain stimulation surgery: prospective targeting in treatment-resistant depression. Mol Psychiatry. 2018 Apr;23(4):843-849. doi: 10.1038/mp.2017.59. Epub 2017 Apr 11.
PubMed 28397839Waters AC, Veerakumar A, Choi KS, Howell B, Tiruvadi V, Bijanki KR, Crowell A, Riva-Posse P, Mayberg HS. Test-retest reliability of a stimulation-locked evoked response to deep brain stimulation in subcallosal cingulate for treatment resistant depression. Hum Brain Mapp. 2018 Dec;39(12):4844-4856. doi: 10.1002/hbm.24327. Epub 2018 Aug 18.
PubMed 30120851Riva-Posse P, Holtzheimer PE, Garlow SJ, Mayberg HS. Practical considerations in the development and refinement of subcallosal cingulate white matter deep brain stimulation for treatment-resistant depression. World Neurosurg. 2013 Sep-Oct;80(3-4):S27.e25-34. doi: 10.1016/j.wneu.2012.11.074. Epub 2012 Dec 13.
PubMed 23246630Crowell AL, Garlow SJ, Riva-Posse P, Mayberg HS. Characterizing the therapeutic response to deep brain stimulation for treatment-resistant depression: a single center long-term perspective. Front Integr Neurosci. 2015 Jun 15;9:41. doi: 10.3389/fnint.2015.00041. eCollection 2015.
PubMed 26124710Riva-Posse P, Choi KS, Holtzheimer PE, McIntyre CC, Gross RE, Chaturvedi A, Crowell AL, Garlow SJ, Rajendra JK, Mayberg HS. Defining critical white matter pathways mediating successful subcallosal cingulate deep brain stimulation for treatment-resistant depression. Biol Psychiatry. 2014 Dec 15;76(12):963-9. doi: 10.1016/j.biopsych.2014.03.029. Epub 2014 Apr 13.
PubMed 24832866Fitoz EC, Alagapan S, Cha J, Choi KS, Figee M, Kopell B, Obatusin M, Heisig S, Nauvel T, Razavilar A, Sarikhani P, Trivedi I, Gowatsky J, Alexander J, Guignon R, Khalid M, Forestal GB, Song HN, Denison T, O'Neill S, Karjagi S, Waters AC, Riva-Posse P, Mayberg HS, Rozell CJ. Common Electrophysiology Biomarkers Collected at Home Robustly Track Depression Recovery With Deep Brain Stimulation. medRxiv [Preprint]. 2026 Apr 20:2026.04.13.26350107. doi: 10.64898/2026.04.13.26350107.
PubMed 42078404
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04106466
- Acronym / sponsor ID
- GCO 17-2763
- Keywords
- Deep Brain Stimulation, Major Depressive Disorder, Treatment resistant depression, subcallosal cingulate white matter, Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Helen Mayberg, MDUniversity, hospital or other
- Collaborators
- Emory University, Georgia Institute of Technology, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be implanted with the study device and receive open label, active DBS stimulation
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation (DBS) | Experimental | Device: Medtronic Summit RC+S DBS systemOpen label active Deep Brain Stimulation (DBS) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 25-70 years old.
- Ability to provide written informed consent.
- Lives within commuting distance to New York City and study location (Mount Sinai West Hospital)
- 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 (SCID). Two independent psychiatrists will confirm the diagnosis.
- Current depressive episode of at least two years duration OR a history of more than 3 lifetime depressive episodes.
Key exclusion criteria (9 listed)
- Other Axis I comorbid 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
- Conditions requiring MRI scans or diathermy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Summit RC+S DBS systemOpen label active Deep Brain Stimulation (DBS) | Device | Deep Brain Stimulation (DBS) |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 28397839Riva-Posse P, Choi KS, Holtzheimer PE, Crowell AL, Garlow SJ, Rajendra JK, McIntyre CC, Gross RE, Mayberg HS. A connectomic approach for subcallosal cingulate deep brain stimulation surgery: prospective targeting in treatment-resistant depression. Mol Psychiatry. 2018 Apr;23(4):843-849. doi: 10.1038/mp.2017.59. Epub 2017 Apr 11.
- Background: PubMed 30120851Waters AC, Veerakumar A, Choi KS, Howell B, Tiruvadi V, Bijanki KR, Crowell A, Riva-Posse P, Mayberg HS. Test-retest reliability of a stimulation-locked evoked response to deep brain stimulation in subcallosal cingulate for treatment resistant depression. Hum Brain Mapp. 2018 Dec;39(12):4844-4856. doi: 10.1002/hbm.24327. Epub 2018 Aug 18.
- Background: PubMed 23246630Riva-Posse P, Holtzheimer PE, Garlow SJ, Mayberg HS. Practical considerations in the development and refinement of subcallosal cingulate white matter deep brain stimulation for treatment-resistant depression. World Neurosurg. 2013 Sep-Oct;80(3-4):S27.e25-34. doi: 10.1016/j.wneu.2012.11.074. Epub 2012 Dec 13.
- Background: PubMed 26124710Crowell AL, Garlow SJ, Riva-Posse P, Mayberg HS. Characterizing the therapeutic response to deep brain stimulation for treatment-resistant depression: a single center long-term perspective. Front Integr Neurosci. 2015 Jun 15;9:41. doi: 10.3389/fnint.2015.00041. eCollection 2015.
- Background: PubMed 24832866Riva-Posse P, Choi KS, Holtzheimer PE, McIntyre CC, Gross RE, Chaturvedi A, Crowell AL, Garlow SJ, Rajendra JK, Mayberg HS. Defining critical white matter pathways mediating successful subcallosal cingulate deep brain stimulation for treatment-resistant depression. Biol Psychiatry. 2014 Dec 15;76(12):963-9. doi: 10.1016/j.biopsych.2014.03.029. Epub 2014 Apr 13.
- Derived from this study: PubMed 42078404Fitoz EC, Alagapan S, Cha J, Choi KS, Figee M, Kopell B, Obatusin M, Heisig S, Nauvel T, Razavilar A, Sarikhani P, Trivedi I, Gowatsky J, Alexander J, Guignon R, Khalid M, Forestal GB, Song HN, Denison T, O'Neill S, Karjagi S, Waters AC, Riva-Posse P, Mayberg HS, Rozell CJ. Common Electrophysiology Biomarkers Collected at Home Robustly Track Depression Recovery With Deep Brain Stimulation. medRxiv [Preprint]. 2026 Apr 20:2026.04.13.26350107. doi: 10.64898/2026.04.13.26350107.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Mayberg, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Summit RC+S DBS system in people with Major Depressive Disorder and Treatment Resistant Depression, run by Helen Mayberg, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04106466, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.