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Deep Brain Stimulation (DBS) for Depression Using Directional Current Steering and Individualized Network Targeting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03437928
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : November 30, 2021
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Sameer Sheth, Baylor College of Medicine

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Directional Deep Brain Stimulation Not Applicable

Detailed Description:
Treatment-resistant depression (TRD) is a major worldwide burden. Major depression has a lifetime prevalence of ~15% across developed countries. Up to a third of patients fail to respond adequately to evidence-based treatments, including pharmacological, behavioral, and electroconvulsive therapy. The investigators employ an innovative approach, including subacute invasive neurophysiological monitoring with which they aim to gain insight into the networks underlying depression symptomatology, confirm the ability to predict the effects of precision DBS on network activity, and harmonize these insights to implement network-guided DBS for TRD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation (DBS) for Depression Using Directional Current Steering and Individualized Network Targeting
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : August 19, 2023
Estimated Study Completion Date : August 19, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Directional Deep Brain Stimulation Device: Directional Deep Brain Stimulation
Boston Scientific Vercise DBS leads and 16-channel implanted pulse generators (IPGs) will be implanted to control the shape and size of stimulation




Primary Outcome Measures :
  1. Changes in depressive symptoms [ Time Frame: 54 to 60 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women (non-pregnant) between ages 22 and 70;
  2. 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;
  3. 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);
  4. 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);
  5. 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;
  6. Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20;
  7. 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;
  8. Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one-week pre-op;
  9. Lifetime exposure to minimal 6 weeks of psychotherapy without sustained response;
  10. 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;
  11. Stable antidepressant medication regimen for the month preceding surgery;
  12. Modified mini-mental state examination (MMSE) score ≥ 24;
  13. Normal thyroid stimulating hormone (TSH) level within 12 months of study entry;
  14. 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;
  15. Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months following surgery;
  16. Must have a treating psychiatrist, a family member, significant other/living partner, a caregiver, or a person known by the subject present at the Screening visit for the discussion about the study before co-signing the informed consent form;
  17. Willingness to sign Treatment Contract;
  18. Agrees to be followed at regular intervals by a licensed psychiatrist and to provide written permission allowing any and all forms of communication between the research team and the subject's healthcare providers, for the entirety of the study.

Exclusion Criteria:

  1. DSM-5 Axis I Disorders: any lifetime history of psychotic disorder (e.g., schizophrenia, schizoaffective disorder);
  2. Bipolar disorder with rapid cycling and history of manic episode requiring hospitalization within the past 5 years;
  3. Clinically significant Cluster A or B personality disorder;
  4. Alcohol or substance use disorder within 6 months, excluding nicotine;
  5. Urine drug test positive for illicit drugs;
  6. 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;
  7. 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);
  8. 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);
  9. Any medical contraindication to surgery such as infection;
  10. 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;
  11. A blood pressure of ≥ 180/110 mmHg at a single visit and evidence of cardiovascular disease (CVD);
  12. Participation in another drug, device, or biological trial within 90 days;
  13. Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators including spinal cord stimulators and deep brain stimulators;
  14. Pregnant or has plans to become pregnant in the next 24 months;
  15. Anticipated need for MRI;
  16. Need for Diathermy;
  17. Chronic use of anticoagulant or anti-platelet agents that cannot be safely stopped for a sufficient duration (minimum 2.5 weeks) in the peri-operative period;
  18. Any Psychiatric/Neurological/Medical condition that makes the subject, in the opinion of the Investigator, a poor candidate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437928


Contacts
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Contact: Sameer A Sheth, MD, PhD 713-798-5060 sameer.sheth@bcm.edu

Locations
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United States, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Nader Pouratian, MD    214-648-9323    nader.pouratian@utsouthwestern.edu   
Contact: Hamasa Ebadi    571-265-5926    hamasa.ebadi@utsouthwestern.edu   
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Victoria Pirtle    713-798-1717    victoria.pirtle@bcm.edu   
Contact: Sameer A Sheth, MD, PhD    713-798-5060    sameer.sheth@bcm.edu   
Principal Investigator: Sameer A Sheth, MD, PhD         
Sponsors and Collaborators
Baylor College of Medicine
University of Texas
Investigators
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Principal Investigator: Sameer A Sheth, MD, PhD Baylor College of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sameer Sheth, Associate Professor, Vice-Chair of Clinical Research, Department of Neurosurgery, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03437928    
Obsolete Identifiers: NCT03964194
Other Study ID Numbers: H-43036
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Sameer Sheth, Baylor College of Medicine:
Major Depressive Disorder (MDD)
MDD
Neuromodulation
Deep Brain Stimulation (DBS)
DBS
Electrophysiology
Imaging
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders