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NCT05773755 · ClinicalTrials.gov registry record · NA
DBS for TRD With the Medtronic Percept PC
A NA study of Major Depressive Disorder and Treatment-Resistant Depression, sponsored by Helen Mayberg, MD.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05773755 is a NA study of Major Depressive Disorder and Treatment-Resistant Depression that is actively recruiting participants, run by Helen Mayberg, MD. The registered enrollment target is 10 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05773755, a NA study of Major Depressive Disorder and Treatment-Resistant Depression, is actively recruiting participants, sponsored by Helen Mayberg, MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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 a DBS device called the Percept PC (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 Percept PC 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 movement, voice, and video recording
Conditions Studied
Interventions
- DEVICE Medtronic Percept PC DBS system
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai, Mount Sinai West - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2028-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05773755
The ClinicalTrials.gov registry entry for NCT05773755 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (97% lower). The listed sponsor is Helen Mayberg, MD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Medtronic Percept PC DBS system is the first listed.
NCT05773755 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05773755 about?
NCT05773755 is a clinical study titled "DBS for TRD With the Medtronic Percept PC". 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 ...
What is the current status of trial NCT05773755?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2023-03-01. Estimated completion is 2028-12.
What conditions does trial NCT05773755 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Treatment-Resistant Depression.
What interventions are being tested in trial NCT05773755?
The interventions under investigation include: Medtronic Percept PC DBS system (DEVICE).
Who is sponsoring clinical trial NCT05773755?
This trial is sponsored by Helen Mayberg, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05773755 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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