Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Nader Pouratian, MD, PhD
Nader.Pouratian@UTSouthwestern.edu
310/274-2095
Backup
Nadia Imran
Nadia.Imran@UTSouthwestern.edu
214/648-7585
Time Frame
Start Date: 2022-10-28
Estimated Completion Date: 2027-07
Participants
Target number of participants: 12
Treatments
Experimental: Randomized Discontinuation Period: OFF then ON DBS
Subjects randomized to this arm are initially OFF DBS after the open label period then gradually decreased in their optimized setting's amplitude for 8 weeks and then ON DBS for 8 weeks.
Experimental: Randomized Discontinuation Period: ON then OFF DBS
Subjects randomized to this arm are initially ON DBS with optimized stimulation settings for 8 weeks after the open label period and then OFF DBS with gradually decreasing amplitude for 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: Nader Pouratian

This content was sourced from clinicaltrials.gov