RightFit
RecruitingNot applicable

DBS for TRD With the Medtronic Percept PC

Deep Brain Stimulation for Treatment Resistant Depression: Exploration of Local Field Potentials (LFPs) With the Medtronic Percept PC System

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests deep brain stimulation (DBS) with the Medtronic Percept PC device in adults whose depression has not improved with treatment. The device is placed during surgery and sends electrical pulses to the brain. Researchers will record brain signals to see how they relate to changes in depression symptoms.

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 20 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 25 to 70 years old and able to give written consent.
  • Have major depression now, without psychosis, such as seeing or hearing things that are not there. Two study psychiatrists must confirm the diagnosis.
  • Have a current bout of depression lasting at least 2 years, or have had more than 3 bouts in your life.
  • Score at least 20 on the study’s depression scale at entry and on average across 4 weekly visits before surgery.
  • Score 50 or lower on a scale that measures how well you manage daily life.
  • Have not improved with at least 4 adequate depression treatments during the current bout, confirmed by medical records. If you have not had ECT (electrical treatment given under anesthesia), you must have tried the listed types of medicines plus TMS (magnetic brain stimulation) and/or ketamine.
  • Be able to follow study steps and manage the device, including twice-daily tasks and weekly in-person visits for up to 1 year.
  • Live in the New York metropolitan area for the first several months of the study.

Who can't join

  • Have another main mental health condition.
  • Have suicidal thoughts with intent to act, a suicide attempt in the past 6 months, more than 3 attempts in the past 2 years, or a serious suicide risk judged by the study doctors.
  • Have another main brain or nerve disorder, or a medical illness that is not stable.
  • Need blood-thinning medicine that cannot be stopped around surgery.
  • Be pregnant or plan to become pregnant during the study.
  • Have a condition that makes general anesthesia, brain surgery, or an MRI scan unsafe.
  • Have a pacemaker, implanted heart shock device, or another implanted electrical device that could interfere with DBS or be affected by it.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

NY