Summary

Eligibility
for people ages 22-65 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Andrew Moses Lee, MD, PhD
Headshot of Andrew Moses Lee
Andrew Moses Lee

Description

Summary

This is a dual-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.

Official Title

A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Multi-Lead Deep Brain Stimulation for Treatment-Refractory Obsessive- Compulsive Disorder (SEEG-Guided DBS for OCD)

Keywords

Obsessive-Compulsive Disorder, Compulsive Personality Disorder, PMT Stereoencephalography (SEEG), Vercise Genus™ Deep Brain Stimulation (DBS) System

Eligibility

You can join if…

Open to people ages 22-65

  1. ≥ 22 years and ≤ 65 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)
  3. Presence of obsessions, compulsions, or both
  4. 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
  5. 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
  6. Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5
  7. Severe OCD symptoms, as defined by Y-BOCS I score of ≥ 28, within two weeks prior to enrollment
  8. 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
  9. 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
  10. Adequate trial of ≥ 1 augmentation trial using an antipsychotic medication
  11. Adequate trial of clomipramine, either as monotherapy or as an augmentation therapy, unless medically contradicted
  12. Adequate trials of cognitive behavior therapy-based Exposure and Response Prevention (ERP)
  13. 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
  14. 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
  15. 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
  16. 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
  17. 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
  18. . 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
  19. . 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
  20. . Ability to understand procedure-related instructions and to complete study assessments in English, in the opinion of the Principal Investigator
  21. . 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
  22. . Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s)
  23. . Willingness and ability to provide informed consent, in the opinion of the Principal Investigator

You CAN'T join if...

  1. Diagnosed, according to the Mini International Neuropsychiatric Interview (MINI), as suffering from any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder
  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. Present clinical secondary diagnosis of any of the following, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
  4. Bipolar I Disorder or Bipolar II Disorder
  5. Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder
  6. Psychotic Disorder or Mood Disorder with psychotic features
  7. 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
  8. Subjects who answer 'Yes' to questions 3, 4, or 5 of the C-SSRS will be excluded.
  9. 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
  10. History of head trauma associated with any of the following:
  11. Loss of consciousness for > 5 minutes
  12. A residual effect(s) that failed to resolve completely at least 1 year prior to the date of screening
  13. An abnormality on a neuroimaging study (MRI, CT Scan) that was/is attributable to the head trauma
  14. > 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
  15. Any of the following permanent implants:
  16. Cardiac implant (e.g. pacemaker or any intracardiac lines, implanted neurostimulators, shunts)
  17. Brain implant (e.g. intracranial implant, aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
  18. Implanted medical pumps
  19. Diathermy treatments requirement for any reason
  20. 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
  21. . Any metal or metallic particles anywhere in the head, except in the inside of the mouth
  22. . Pregnancy, at the time of screening or during the course of the study (i.e. 3 years)
  23. 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.
  24. . History of involuntary movements, in the opinion of the Principal Investigator or a neuro-radiologist
  25. . History of excessive or prolonged bleeding and/or any of the following:
  26. INR of > 1.8
  27. Prolonged activated partial thromboplastin time (aPTT) of ≥ 45 sec
  28. Platelet count of < 75×100/L
  29. . Allergy to gadolinium
  30. . Inability to safely and successfully undergo an MRI or a CT Scan
  31. . 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
  32. . 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

Locations

  • University of California
    San Francisco California 94143 United States
  • University of Pennsylvania
    Philadelphia Pennsylvania 19106 United States

Lead Scientist at UCSF

  • Andrew Moses Lee, MD, PhD
    Assistant Professor, Psychiatry, School of Medicine. Authored (or co-authored) 8 research publications. Research interests: OCD · Tic Disorder · Anxiety-Spectrum Disorders · Neuromodulation · Neural Circuits

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Casey H. Halpern, M.D.
ID
NCT05623306
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated