DBS for Depression

NCT03437928 | Recruiting DMC FDA Device

• 1 other identifier: H-43036
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of the study is to address the unmet need of TRD patients by identifying brain networks critical for treating depression and to use next generation precision DBS with steering capability to engage these targeted networks. The study's goal will be achieved through 3 specific aims:

1. 1.Demonstrate device capability to selectively and predictably engage distinct brain networks
2. 2.Delineate depression-relevant networks and demonstrate behavioral changes with network-targeted stimulation
3. 3.Demonstrate that chronic DBS using steered, individualized targeting is feasible and safe for reducing depressive symptoms

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder (MDD); MDD; Neuromodulation; Deep Brain Stimulation (DBS); DBS; Electrophysiology; Imaging

Outcome Measures

Primary Outcomes (1)

• Changes in depressive symptoms

  Response will be defined as 50% decrease in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline. The range is from 0 to 60 and a score higher than 20 indicates moderate to severe depression.

  54 to 60 months

Study Arms (1)

Directional Deep Brain Stimulation

EXPERIMENTAL

Device: Directional Deep Brain Stimulation

Interventions

Directional Deep Brain Stimulation DEVICE

Boston Scientific Vercise DBS leads and 16-channel implanted pulse generators (IPGs) will be implanted to control the shape and size of stimulation

Directional Deep Brain Stimulation

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women (non-pregnant) between ages 22 and 70;
• DSM-5 diagnosis (assessed by Structured Clinical Interview for DSM-5 Axis I disorders SCID-5) of major depression disorder (MDD) as the primary diagnosis. A current major depressive episode (MDE), recurrent or single episode with first episode before age 60, secondary to nonpsychotic unipolar major depressive disorder;
• Chronic illness with current MDE ≥24 months duration and/or recurrent illness with at least a total of 2 lifetime episodes (including current episode \>12 months);
• Treatment resistance (defined by criteria on the Antidepressant Treatment History Form ATHF): Failure (i.e. persistence of the major depressive episode) to respond to a minimum of four adequate depression treatments from at least two different treatment categories (e.g. SSRIs, SNRIs, TCAs, other antidepressants, lithium-addition, irreversible MAOIs, antidepressant augmentation with an atypical antipsychotic medication);
• Previous trial of Electroconvulsive Therapy (ECT) (lifetime): either did not respond, relapsed, poorly tolerated or refused. If refused, will discuss reasons and ensure subject understands relative risks of ECT versus DBS. We will try to enrich sample with patients who had previously shown response to ECT (or another intervention) that was partial or un-sustained;
• Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20;
• The HDRS17 must remain greater than or equal to 20 on two separate assessments (at initial screening and 1 week before surgery), over a 1-month period;
• Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one-week pre-op;
• Lifetime exposure to minimal 6 weeks of psychotherapy without sustained response;
• Must have a brain MRI within 3 months of enrollment that is "normal", according to the radiology report, or does not reveal any findings that in the opinion of the Investigator preclude participation in the study;
• Stable antidepressant medication regimen for the month preceding surgery;
• Modified mini-mental state examination (MMSE) score ≥ 24;
• Normal thyroid stimulating hormone (TSH) level within 12 months of study entry;
• The patient does not have any medical or physical conditions which, in the opinion of the Investigator, make it unlikely the patient will be able to participate for the duration of the study;
• Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months following surgery;

You may not qualify if:

• DSM-5 Axis I Disorders: any lifetime history of psychotic disorder (e.g., schizophrenia, schizoaffective disorder);
• Bipolar disorder with rapid cycling and history of manic episode requiring hospitalization within the past 5 years;
• Clinically significant Cluster A or B personality disorder;
• Alcohol or substance use disorder within 6 months, excluding nicotine;
• Urine drug test positive for illicit drugs;
• Any evidence or indication of suicidal intent, suicidal attempt, or suicidal behavior, including but not limited to the C-SSRS score, within the past one year;
• Neurological/Medical condition that makes the patient, in the opinion of the surgeon, a poor surgical candidate (e.g., progressive neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic anticoagulation);
• Any history of seizure disorder, hemorrhagic stroke, or has high risk of seizure (history of congenital malformation, history of brain injury, neuro-developmental disorder, currently taking medication that is known to lower seizure threshold, or other factors that predispose seizures);
• Any medical contraindication to surgery such as infection;
• Coagulopathy: Bleeding propensity and/or one of the following: INR \> 1.5; prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec; platelet count \< 100×103/uL;
• A blood pressure of ≥ 180/110 mmHg at a single visit and evidence of cardiovascular disease (CVD);
• Participation in another drug, device, or biological trial within 90 days;
• Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators including spinal cord stimulators and deep brain stimulators;
• Pregnant or has plans to become pregnant in the next 24 months;
• Anticipated need for MRI;

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of Texas: collaborator

Study Sites (2)

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Related Publications (2)

• Noecker AM, Mlakar J, Bijanki KR, Griswold MA, Pouratian N, Sheth SA, McIntyre CC. Stereo-EEG-guided network modulation for psychiatric disorders: Interactive holographic planning. Brain Stimul. 2023 Nov-Dec;16(6):1799-1805. doi: 10.1016/j.brs.2023.11.003. Epub 2023 Dec 20.

  PMID: 38135359 DERIVED

• Powell MP, Anso J, Gilron R, Provenza NR, Allawala AB, Sliva DD, Bijanki KR, Oswalt D, Adkinson J, Pouratian N, Sheth SA, Goodman WK, Jones SR, Starr PA, Borton DA. NeuroDAC: an open-source arbitrary biosignal waveform generator. J Neural Eng. 2021 Feb 5;18(1):10.1088/1741-2552/abc7f0. doi: 10.1088/1741-2552/abc7f0.

  PMID: 33152715 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sameer A Sheth, MD, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sameer A Sheth, MD, PhD

CONTACT

713-798-5060; sameer.sheth@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice-Chair of Clinical Research, Department of Neurosurgery

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: February 19, 2018
• Study Start: August 20, 2019
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (2)