Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
Study NCT ID:
NCT04106466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-29
First Post:
2019-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DBS for TRD With the Medtronic Summit RC+S
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-14', 'size': 702739, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-17T12:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'N/A. This is open label study.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will be implanted with the study device and receive open label, active DBS stimulation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hamilton Depression Rating Scale (HDRS) score', 'timeFrame': 'Baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Baseline; after 6 months of continuous active stimulation; after 1 year of continuous active stimulation', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Deep Brain Stimulation', 'Major Depressive Disorder', 'Treatment resistant depression', 'subcallosal cingulate white matter', 'Depression'], 'conditions': ['Major Depressive Disorder', 'Treatment Resistant Depression']}, 'referencesModule': {'references': [{'pmid': '28397839', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30120851', 'type': 'BACKGROUND', 'citation': 'Waters 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.'}, {'pmid': '23246630', 'type': 'BACKGROUND', 'citation': 'Riva-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.'}, {'pmid': '26124710', 'type': 'BACKGROUND', 'citation': 'Crowell 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.'}, {'pmid': '24832866', 'type': 'BACKGROUND', 'citation': 'Riva-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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nBy 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 25-70 years old.\n* Ability to provide written informed consent.\n* Lives within commuting distance to New York City and study location (Mount Sinai West Hospital)\n* 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.\n* Current depressive episode of at least two years duration OR a history of more than 3 lifetime depressive episodes.\n* Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17)\n* 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.\n* A maximum Global Assessment of Functioning of 50 or less.\n* Confirmed to have treatment-resistant depression (TRD). Treatment-resistance will be defined as:\n\n 1. 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.\n 2. 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.\n* Able to undergo preoperative MRI\n* Have a designated caregiver available to assist in compliance with study procedures\n* Willing and able to comply with all study-related appointments and procedures\n\nExclusion criteria:\n\n* Other Axis I comorbid conditions\n* 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\n* Other primary neurological disorders or unstable medical illness\n* Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required\n* Conditions requiring MRI scans or diathermy\n* Pregnancy or plan to come pregnant during the study\n* Contraindications for general anesthesia, neurosurgery, or an MRI scan\n* 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.\n* Patients who lack the capacity for proper device usage and maintenance, in the opinion of the research team"}, 'identificationModule': {'nctId': 'NCT04106466', 'briefTitle': 'DBS for TRD With the Medtronic Summit RC+S', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Deep Brain Stimulation (DBS) for Treatment Resistant Depression: Exploration of Local Field Potentials (LFPs) With the Medtronic Summit RC+S "Brain Radio" System', 'orgStudyIdInfo': {'id': 'GCO 17-2763'}, 'secondaryIdInfos': [{'id': '5UH3NS103550', 'link': 'https://reporter.nih.gov/quickSearch/5UH3NS103550', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deep Brain Stimulation (DBS)', 'description': 'Open label active Deep Brain Stimulation (DBS)', 'interventionNames': ['Device: Medtronic Summit RC+S DBS system']}], 'interventions': [{'name': 'Medtronic Summit RC+S DBS system', 'type': 'DEVICE', 'description': 'Open label active Deep Brain Stimulation (DBS)', 'armGroupLabels': ['Deep Brain Stimulation (DBS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai, Mount Sinai West', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Helen Mayberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'url': 'https://dabi.loni.usc.edu', 'infoTypes': ['ICF'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary) identified for this purpose may request access to individual participant data meta-analysis. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (https://dabi.loni.usc.edu).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helen Mayberg, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Emory University', 'class': 'OTHER'}, {'name': 'Georgia Institute of Technology', 'class': 'OTHER'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Departments of Neurology, Neurosurgery, Neuroscience, Psychiatry', 'investigatorFullName': 'Helen Mayberg, MD', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}