RECRUITING

Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

Quick Facts

Study Start:2022-10-28
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03952962

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women (non-pregnant) between ages 21 and 70;
  2. * 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;
  3. * Current index MDE ≥24 months duration and/or recurrent illness with at least a total of 2 lifetime episodes (including current episode \>12 months);
  4. * 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;
  5. * Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20;
  6. * Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one week pre-op;
  7. * Normal brain MRI within 3 months of surgery;
  8. * Antidepressant medication regimen has been held stable for ≥ 30 days prior to the study screening MADRS;
  9. * Remain on stable antidepressant medication throughout the study, unless there are safety concerns;
  10. * Montreal Cognitive Assessment (MoCA) \>25;
  11. * Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months.
  1. * DSM-5 Axis I Disorders: any lifetime history of psychotic disorder or bipolar disorder;
  2. * Alcohol or substance use disorder within 6 months, excluding nicotine;
  3. * History of childhood abuse (physical or sexual) 18
  4. * Personality disorders;
  5. * Seeking disability during the trial;
  6. * 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);
  7. * No stable work history;
  8. * Neurological/Medical condition that makes the patient, in the opinion of the surgeon, a poor candidate;
  9. 1. Pregnant or has plans to become pregnant in the next 36 months;
  10. 2. Unable/unable to practice birth control through the period of randomization and withdrawal of therapy;
  11. * Subjects who have a history of a seizure disorder;
  12. * Subjects who will be exposed to diathermy;
  13. * Subjects who have any medical contraindications to undergoing DBS surgery (e.g. infection, coagulopathy, or significant cardiac or other medical risk factors for surgery);
  14. * Subjects with another implanted device such as a cardiac pacemaker, defibrillator or neurostimulator;
  15. * Subjects who have a history of hemorrhagic stroke;
  16. * Subjects who are unable to undergo MRI;
  17. * Subjects who are at increased risk of hemorrhage due to underlying medical conditions or medication.

Contacts and Locations

Study Contact

Nader Pouratian, MD, PhD
CONTACT
310/274-2095
Nader.Pouratian@UTSouthwestern.edu
Nadia Imran
CONTACT
214/648-7585
Nadia.Imran@UTSouthwestern.edu

Principal Investigator

Nader Pouratian, MD, PhD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Nader Pouratian

  • Nader Pouratian, MD, PhD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-28
Study Completion Date2025-07

Study Record Updates

Study Start Date2022-10-28
Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

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