🏛️ Verified NIH Record • Updated 2026-02-19

Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression (NCT02046330)

Deep Brain Stimulation (DBS) Therapy for Treatment Resistant

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: The University of Texas Health Science Center, Houston

🩺 Plain-English Summary (8th-Grade Level)

We propose a clinical study of medial forebrain bundle DBS as a treatment in 20 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Percept™ PC system manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 70 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (18 items).

Location: UT Center of Excellence on Mood Disorders — Houston, Texas

Age range: 22 Years to 70 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Current or past non-affective psychotic disorder, Bipolar Disorder, Schizophrenia, or Schizoaffective disorder. Patients who suffer from generalized anxiety disorder will be permitted to participate as long as MDD is the primary clinical diagnosis.
  • Any current clinically significant neurological disorder, including dementia or medical illness affecting brain function.
  • Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
  • Any previous surgery to destroy the region of the brain that will be the target of treatment.
  • Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, implantable defibrillator or other implantable stimulator, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
  • Refusal of an adequate trial of ECT.
  • History of stimulation intolerance in any area of the body.
  • Current or unstably remitted substance abuse or dependence. No alcohol and/or substance abuse or dependence in the past 6 months.
  • Pregnancy and women of childbearing age not using effective contraception. Double-barrier method is required.
  • History of severe personality disorder, where, based on the judgment of the investigators, the personality disorder will interfere with the patient's ability to complete the follow-up protocol, e.g. borderline personality disorder.
  • Imminent risk of suicide

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • UT Center of Excellence on Mood Disorders — Houston, Texas

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗