| Eligibility |
Inclusion Criteria:
1. = 22 years and = 75 years of age, at the time of screening
2. 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)
1. Presence of obsessions, compulsions, or both
2. Time-consuming obsessions and compulsions that take more than one hour a day or
cause clinically significant distress or impairment in social, occupational, or
other important areas of functioning
3. Obsessive-compulsive symptoms that are not attributable to the physiological
effects of a substance (e.g. a drug of abuse, a medication) or another medical
condition
4. Disturbance not better explained by the symptoms of another mental disorder
listed in the DSM-5
3. Severe OCD symptoms, as defined by Y-BOCS I score of = 28, within two weeks prior to
enrollment
4. 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
1. Adequate trial of = 2 selective serotonin reuptake inhibitors (SSRIs) for an
adequate duration at the maximum dose recommended for OCD or at the
maximally-tolerated dose according to the FDA-approved package labeling
2. Adequate trial of = 1 augmentation trial using an antipsychotic medication
3. Adequate trial of clomipramine, either as monotherapy or as an augmentation
therapy, unless medically contradicted
4. Adequate trials of cognitive behavior therapy-based Exposure and Response
Prevention (ERP)
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
12. Ability to understand procedure-related instructions and to complete study assessments
in English, in the opinion of the Principal Investigator
13. 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
14. Willingness and ability to provide written agreement to allow any and all forms of
communication between the research team and treating clinician(s)
15. Willingness and ability to provide informed consent, in the opinion of the Principal
Investigator
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 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
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 < 75×100/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
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