Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

NCT ID: NCT03952962

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2027-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Abbott Laboratories Infinity™ implantable deep brain stimulation system

Intervention Type: DEVICE

Deep brain stimulation (DBS) refers to the process of delivering an electrical current to a precise location in the brain.

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.

Group Type: EXPERIMENTAL

Abbott Laboratories Infinity™ implantable deep brain stimulation system

Intervention Type: DEVICE

Deep brain stimulation (DBS) refers to the process of delivering an electrical current to a precise location in the brain.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nader Pouratian

OTHER

Sponsor Role: lead

Responsible Party

Nader Pouratian

PROFESSOR & CHAIR

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nader Pouratian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nader Pouratian, MD, PhD

Role: CONTACT

Nader.Pouratian@UTSouthwestern.edu

310/274-2095

Nadia Imran

Role: CONTACT

Nadia.Imran@UTSouthwestern.edu

214/648-7585

Facility Contacts

Nader Pouratian, MD, PhD

Role: primary

Nader.Pouratian@UTSouthwestern.edu

310-274-2095

Other Identifiers

19-000767; STU-2021-0635

Identifier Type: -

Identifier Source: org_study_id