SEEG-Guided DBS for OCD

Exclusion Criteria

• •1. Diagnosis of, according to the Mini International Neuropsychiatric Interview (MINI), any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder.
• •a. Subjects with secondary psychiatric diagnosis will not be excluded, except as described below.
• •2. In the opinion of the Principal Investigator and relative to the date of enrollment, (a) current or past diagnosis of, or medical history/records suggestive of, a DSM-5 defined Personality Disorder, considered to be severe; or (b) history of hospitalization because of Borderline Personality Disorder
• •3. Clinical secondary diagnosis made by a psychiatrist, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
• •1. Lifetime diagnosis of Bipolar I Disorder or Bipolar II Disorder
• •2. Current/active diagnosis of Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder
• •i. Diagnosis will be considered current/active if the subject had an active episode within 5 years of screening. c. Lifetime diagnosis of a primary psychotic disorder (e.g. Schizophrenia, Schizoaffective Disorder) d. Current/active diagnosis of mood disorder with psychotic features i. Diagnosis will be considered current/active if the subject had an active episode within 2 years of screening.
• •4. Current suicidal risk, as determined by the research/study psychiatrist using the brief mental status exam and the psychiatric interview (including the Columbia Suicide Severity Rating Scale \[C-SSRS\]), or significant suicide risk, defined as Hamilton Depression Rating Scale (HDRS-21) Item 3 score of ≥ 3 or any lifetime history of suicide attempt
• •a. Subjects who answer 'Yes' to questions 3, 4, or 5 of the C-SSRS will be excluded.
• •5. Treatment, within two years of screening, for any of the following: dependency on, addiction to, use of, abuse of, or overuse of any illicit substance(s), including alcohol, but not including nicotine or caffeine
• •6. History of head trauma associated with any of the following:
• •1. Loss of consciousness for \> 5 minutes
• •2. A residual effect(s) that failed to resolve completely at least 1 year prior to the date of screening
• •3. An abnormality on a neuroimaging study (MRI, CT Scan) that was/is attributable to the head trauma
• •4. \> 1 head injury within the past 2 years which were diagnosed as a concussion, concussive-type or traumatic brain injury (TBI), according to medical records or as reported by the prospective subject or a family member
• •7. Any of the following permanent implants:
• •1. Cardiac implant (e.g. pacemaker or any intracardiac lines, implanted neurostimulators, shunts)
• •2. Brain implant (e.g. intracranial implant, aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
• •3. Implanted medical pumps
• •8. Diathermy treatments requirement for any reason
• •9. Hearing loss that, in the opinion of the Principal Investigator, an audiologist, or a treating physician, is likely to affect the subject's ability to comply with all of the requirements of the study or may affect the integrity of the study data
• •10. Any metal or metallic particles anywhere in the head, except in the inside of the mouth
• •11. Pregnancy, at the time of screening or during the course of the study (i.e. 3 years)
• •a. Acceptable methods of contraception include the following: i. Established use of oral, injected or implanted contraceptives ii. Placement of an intrauterine device (IUD) or an intrauterine system (IUS) iii. Female sterilization (e.g. surgical bilateral oophorectomy with or without hysterectomy, total hysterectomy, tubal ligation) iv. Male sterilization, with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate v. True abstinence, when in line with the preferred and usual lifestyle of the subject b. Barrier methods of contraception, such as a condom, a diaphragm, or cervical/vault caps with spermicidal foam/gel/film/cream/suppository, and rhythm methods of contraception, although encouraged, alone are not considered acceptable forms or contraception.
• •12. History of involuntary movements, in the opinion of the Principal Investigator or a neuro-radiologist
• •13. History of excessive or prolonged bleeding and/or any of the following:
• •1. INR of \> 1.8
• •2. Prolonged activated partial thromboplastin time (aPTT) of ≥ 45 sec
• •3. Platelet count of \< 100×100/L
• •14. Allergy to gadolinium
• •15. Inability to safely and successfully undergo an MRI or a CT Scan
• •16. Any past or present medical condition, disease, disorder, or injury that, in the opinion of the Principal Investigator, may reduce or hinder the subject's ability to fully comply with all study requirements for the duration of the study or may impact, compromise, or affect the integrity of the data or the results of the study
• •17. Current participation in other research that may potentially interfere with DBS study objectives or with the ability to follow the timeline of this study, as determined by the Principal Investigator