Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

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.