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Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

Who can join

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

Age
21 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

  • Procedures mentioned: MRI scans

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
  • "The investigators will use a novel approach using advanced imaging technique (magnetic resonance tractography) to evaluate the feasibility and safety of this surgical approach."
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

Treatment resistant depression remains a major problem for individuals and society. Surgical procedures may provide relief for some of these patients. The most frequently considered surgical approach is deep brain stimulation (DBS) of a part of the brain called the subcallosal cingulate region. However, the effectiveness and safety is not well established. The investigators will use a novel approach using advanced imaging technique (magnetic resonance tractography) to evaluate the feasibility and safety of this surgical approach. An innovative method for the definition of DBS target will be applied that redefines the concept of targeting as one of targeting a symptomatic network rather than a structural brain region using subject-based brain anatomy to define the target location. The correlation between imaging findings at baseline with the mood score changes at different time points of the study will be investigated.

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

Eligibility

Official eligibility criteria

Inclusion Criteria: * Men and women (non-pregnant) between ages 21 and 70; * DSM-5 diagnosis a current major depressive episode (MDE) for 10 years of less, recurrent or single episode with first episode after adulthood and did not start during childhood or adolescence, secondary to nonpsychotic unipolar major depressive disorder; * Current index 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)28): Failure to respond to a minimum of four adequate depression treatments from different categories; * Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20; * Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one week pre-op; * Normal brain MRI within 3 months of surgery; * Antidepressant medication regimen has been held stable for ≥ 30 days prior to the study screening MADRS; * Remain on stable antidepressant medication throughout the study, unless there are safety concerns; * Montreal Cognitive Assessment (MoCA) \>25; * Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months. Exclusion Criteria: * DSM-5 Axis I Disorders: any lifetime history of psychotic disorder or bipolar disorder; * Alcohol or substance use disorder within 6 months, excluding nicotine; * History of childhood abuse (physical or sexual) 18 * Personality disorders; * Seeking disability during the trial; * Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or made any suicide attempt within the last year; (MADRS ≥ 5 including the day of surgery); * No stable work history; * Neurological/Medical condition that makes the patient, in the opinion of the surgeon, a poor candidate; 1. Pregnant or has plans to become pregnant in the next 36 months; 2. Unable/unable to practice birth control through the period of randomization and withdrawal of therapy; * Subjects who have a history of a seizure disorder; * Subjects who will be exposed to diathermy; * Subjects who have any medical contraindications to undergoing DBS surgery (e.g. infection, coagulopathy, or significant cardiac or other medical risk factors for surgery); * Subjects with another implanted device such as a cardiac pacemaker, defibrillator or neurostimulator; * Subjects who have a history of hemorrhagic stroke; * Subjects who are unable to undergo MRI; * Subjects who are at increased risk of hemorrhage due to underlying medical conditions or medication.

Study sites (1)

TX