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About
This is a multi-site, double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of DBS surgery and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
≥ 22 years and ≤ 75 years of age, at the time of screening
Chronic (> 5 years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)
Severe OCD symptoms, as defined by Y-BOCS I score of ≥ 28, within two weeks prior to enrollment
Lack of adequate response to a history of the following treatments, based on information from any of the following: (a) the current treating physician and/or psychologist; (b) medical records or other forms of communication from previous healthcare providers; and (c) pharmacy records, as determined by the Principal Investigator
Willingness and ability to remain on the same daily dose of any and all scheduled psychotropic medication(s) for at least 8 weeks prior to study enrollment and for the duration of the trial, in the opinion of the Principal Investigator
Willingness and ability to discontinue any psychotherapeutic behavioral intervention therapy (e.g. CBT) until the maintenance stage, if determined safe by the research/study psychiatrist
Study participation in the prospective subject's best psychiatric interest, as determined by the research/study psychiatrist and based on a comprehensive assessment that includes the following: (a) detailed psychiatric history; (b) examination of the mental status; (c) review of psychiatric assessment measures obtained to determine eligibility, as applicable; (d) review of previous medical records for a minimum of 2 years prior to enrollment, or as applicable; and (e) consideration of the potential benefits versus risks of study participation
Agreement to being evaluated by a licensed psychiatrist and/or psychologist at regular intervals, as required by the schedule of events, for the duration of study participation
Living within 6 hours of driving distance from study sites and no plan of relocation for at least the duration of the trial (approximately 18-24 months), as reported by the prospective subject or a family member
Adequate social support, including but not limited to, stable housing and two family members and/or friends, who are identified as a verifiable emergency contacts
Willingness and ability to provide at least two verifiable contacts for emergency purposes and to permit verification of emergency contacts by research staff before all study visits and as needed, at the discretion of the Principal Investigator
Ability to understand procedure-related instructions and to complete study assessments in English, in the opinion of the Principal Investigator
Willingness and ability to comply with protocol requirements (e.g. procedure visits, treatment schedule, follow-up visit schedule, evaluations, etc.), in the opinion of the Principal Investigator
Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s)
Willingness and ability to provide informed consent, in the opinion of the Principal Investigator
Exclusion criteria
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.
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
Clinical secondary diagnosis made by a psychiatrist, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
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.
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.
Treatment, within 24 months 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
History of head trauma associated with any of the following:
Any of the following permanent implants:
Diathermy treatments requirement for any reason
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
Any metal or metallic particles anywhere in the head, except in the inside of the mouth
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.
History of involuntary movements, in the opinion of the Principal Investigator or a neuro-radiologist
History of excessive or prolonged bleeding and/or any of the following:
Allergy to gadolinium
Inability to safely and successfully undergo an MRI or a CT Scan
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
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
Primary purpose
Allocation
Interventional model
Masking
10 participants in 2 patient groups
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Central trial contact
Nida Firdous, MD, MS; Giovanna Rocchio
Data sourced from clinicaltrials.gov
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