Deep brain stimulation for treatment-resistant depression using advanced imaging techniques

Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

This study is testing whether deep brain stimulation can help people with treatment-resistant depression by using advanced imaging to better target the areas of the brain involved in their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 21 Years to 70 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT03952962 on ClinicalTrials.gov

What this trial studies

This study investigates the use of deep brain stimulation (DBS) in the subcallosal cingulate region for patients suffering from treatment-resistant depression. By employing advanced magnetic resonance tractography, the researchers aim to redefine the targeting of DBS to focus on symptomatic networks rather than just structural brain regions. The study will assess the feasibility and safety of this innovative approach, correlating imaging findings with mood score changes over time. Participants will undergo surgery with the Abbott Laboratories Infinity™ implantable DBS system.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 21 to 70 with a diagnosis of major depressive disorder who have not responded to multiple antidepressant treatments.

Not a fit: Patients with depression not meeting the treatment-resistant criteria or those with a history of childhood or adolescent onset depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide significant relief for patients with treatment-resistant depression who have not responded to conventional therapies.

How similar studies have performed: While deep brain stimulation has been explored in other studies for depression, this specific approach using advanced imaging techniques is novel and has not been widely tested.

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.

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Nader Pouratian, MD, PhD — University of Texas Southwestern Medical Center
• Study coordinator: Nader Pouratian, MD, PhD

Conditions Treatment Resistant Depression; Undergoing Deep Brain Stimulation Surgery