NCT03952962

Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Nader Pouratian · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Resistant Depression
• Undergoing Deep Brain Stimulation (DBS) Surgery

Interventions

Type	Name	Description
DEVICE	Abbott Laboratories Infinity™ implantable deep brain stimulation system	Deep brain stimulation (DBS) refers to the process of delivering an electrical current to a precise location in the brain.

Timeline

• Start date: 2022-10-28
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2019-05-16
• Last updated: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study