DBS for TRD With the Medtronic Percept PC

Sponsor

Helen Mayberg, MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT05773755

Collaborator

(none)

Enrollment

Location

Arm

69.1

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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 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 recordings. A brief discontinuation experiment will be conducted after 6 months of stimulation, in which the stimulation will be turned off and patterns of LFP changes will be recorded. The entire study is expected to last about 5 years, parcellated into several study phases. All participants are required to live in the New York metropolitan area for the first several months of the study.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Treatment Resistant Depression	Device: Medtronic Percept PC DBS system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All participants will be implanted with the study device and receive open label, active DBS stimulationAll 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 for Treatment Resistant Depression: Exploration of Local Field Potentials (LFPs) With the Medtronic Percept PC System

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deep Brain Stimulation (DBS) for Treatment Resistant Depression Open label active Deep Brain Stimulation (DBS)	Device: Medtronic Percept PC DBS system Open label active Deep Brain Stimulation (DBS)

Arm

Intervention/Treatment

Experimental: Deep Brain Stimulation (DBS) for Treatment Resistant Depression

Open label active Deep Brain Stimulation (DBS)

Device: Medtronic Percept PC DBS system

Open label active Deep Brain Stimulation (DBS)

Outcome Measures

Primary Outcome Measures

Change in Hamilton Depression Rating Scale (HDRS) score [baseline and up to 1 year]
Response to intervention defined as a decrease in the HDRS-17 score of 50% or greater from the 4-week average pre-surgical baseline. Clinical remission will be defined as an HDRS-17 score ≤ 7. Partial response will be defined as a decrease in HDRS-17 >30% but less than 50%. Non-response will be defined as a <30% decrease in HDRS-17. The score for Hamilton Depression Rating Scale, 17 item version, ranges from 0-50, with a higher score indicating more severe depression.

Secondary Outcome Measures

Change in Montgomery-Asberg Depression Rating Scale (MADRS) [baseline and up to 1 year]
The MADRS consists of 10 items evaluating core symptoms of depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0 to 6 continuum (0 = no abnormality, 6 = severe). Scores range from 0 to 60, with higher total scores indicating increased severity of depressive symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 25-70 years old.
Ability to provide written informed consent.
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 or DSM-5 (SCID-IV or SCID-5). Two independent psychiatrists will confirm the diagnosis, as well.
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
Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery)
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 at least four adequate antidepressant treatments (assessed with the Antidepressant Treatment History Form [ATHF-SF] and verified through medical records) during the current episode. Treatments which support study inclusion include antidepressive medications, certain augmentation agents, evidenced-based psychotherapy, and neuromodulation (ECT, transcranial magnetic stimulation (TMS)). For those patients who have not received ECT, patients may be considered eligible for study participation if they have received adequate trials of an SSRI, SNRI, augmentation agent (certain atypical antipsychotic medications, Lithium), and TMS and/or ketamine.
ability comply with study and device management procedures.

Exclusion criteria:

Other primary Axis I 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
Pregnancy or plan to come pregnant during the study
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai, Mount Sinai West	New York	New York	United States	10019

Sponsors and Collaborators

Helen Mayberg, MD

Investigators

Principal Investigator: Helen Mayberg, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Helen Mayberg, MD, Professor, Neurology, Neurosurgery, Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai

ClinicalTrials.gov Identifier:

NCT05773755

Other Study ID Numbers:

STUDY-22-01731

First Posted:

Mar 17, 2023

Last Update Posted:

Mar 17, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Depressive Disorder, Major

Depressive Disorder, Treatment-Resistant

Study Results

No Results Posted as of Mar 17, 2023