Ignite Creation Date:
2024-05-06 @ 1:43 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04106466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-11
First Post:
2019-09-25
Brief Title:
DBS for TRD With the Medtronic Summit RCS
Sponsor:
Helen Mayberg MD
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Deep Brain Stimulation DBS for Treatment Resistant Depression Exploration of Local Field Potentials LFPs With the Medtronic Summit RCS Brain Radio System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 RCS 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 RCS 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
By using an experimental prototype DBS device called the Summit RCS 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 RCS 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5UH3NS103550 | NIH | None | httpsreporternihgovquickSearch5UH3NS103550 |