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Double Blind Randomized Controlled Trial of Deep Brain Stimulation for Obsessive- Compulsive Disorder: Clinical Trial Design

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Double Blind Randomized Controlled Trial of Deep Brain Stimulation for Obsessive- Compulsive Disorder: Clinical Trial Design UC San Diego UC San Diego Previously Published Works Title Double blind randomized controlled trial of deep brain stimulation for obsessive- compulsive disorder: Clinical trial design. Permalink https://escholarship.org/uc/item/93m0r1w4 Authors McLaughlin, Nicole CR Dougherty, Darin D Eskandar, Emad et al. Publication Date 2021-06-05 DOI 10.1016/j.conctc.2021.100785 Peer reviewed eScholarship.org Powered by the California Digital Library University of California Contemporary Clinical Trials Communications 22 (2021) 100785 Contents lists available at ScienceDirect Contemporary Clinical Trials Communications journal homepage: www.elsevier.com/locate/conctc Double blind randomized controlled trial of deep brain stimulation for obsessive-compulsive disorder: Clinical trial design Nicole C.R. McLaughlin a,b,*, Darin D. Dougherty c,d, Emad Eskandar c,d,1,2, Herbert Ward e, Kelly D. Foote f, Donald A. Malone g, Andre Machado g, William Wong h, Mark Sedrak i, Wayne Goodman j,3, Brian H. Kopell j, Fuad Issa k, Donald C. Shields l, Osama A. Abulseoud m, Kendall Lee n, Mark A. Frye n, Alik S. Widge c,d,o,4, Thilo Deckersbach p, Michael S. Okun f, Dawn Bowers q, Russell M. Bauer q, Dana Mason e, Cynthia S. Kubu g, Ivan Bernstein h, Kyle Lapidus r, David L. Rosenthal j,5, Robert L. Jenkins k, Cynthia Read a, Paul F. Malloy a,b, Stephen Salloway a,b, David R. Strong s, Richard N. Jones b, Steven A. Rasmussen a,b, Benjamin D. Greenberg a,b,t a Butler Hospital, 345 Blackstone Blvd, Providence, RI, 02906, USA b Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA c Massachusetts General Hospital, 149 13th Street; Charlestown, MA, 02129, USA d Harvard Medical School, 25 Shattuck St., Boston, MA, 02115, USA e Department of Psychiatry, UF Health Springhill, University of Florida, 4037 NW 86th Terrace, Gainesville, FL, 32606, USA f Norman Fixel Institute of Neurological Diseases, Department of Neurology, University of Florida, 3009 SW Williston Dr., Gainesville, FL, 32608, USA g Cleveland Clinic Neurological Institute, 9500 Euclid Ave., Cleveland, OH, 44195, USA h Kaiser Permanente, 1100 Veterans Blvd., Redwood City, CA, 94063, USA i Kaiser Permanente, Department of Neurosurgery, 1150 Veterans Blvd., Redwood City, CA, 94063, USA j Department of Psychiatry, Icahn School of Medicine at Mount Sinai, 1000 10th Avenue, New York, NY, 10011, USA k Department of Psychiatry & Behavioral Sciences, School of Medicine & Health Sciences, George Washington University, 2120 L Street, NW, Suite 600, Washington, DC, 20037, USA l Department of Neurosurgery, The George Washington University, 2150 Pennsylvania Ave., NW, Ste. 7-409 Washington, DC, 20037, USA m Neuroimaging Research Branch at the National Institute on Drug Abuse, 251 Bayview Boulevard, Baltimore, MD, 21224, USA n Mayo Clinic College of Medicine, 200 First Street SW, Rochester MN, 55901, USA o Massachusetts Institute of Technology, 77 Massachusetts Ave, Cambridge, MA, 02139, USA p University of Applied Sciences Europe, Dessauer Str. 3-5, 10963, Berlin, Germany q Department of Clinical & Health Psychology, University of Florida, PO Box 100165, Gainesville, FL, 32610, USA r Northwell Health, 300 West 72 Street, #1D, New York, NY, 10023, USA s Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, La Jolla, Ca, 92093, USA t Center for Neurorestoration & Neurotechnology, Providence VA Medical Center, 830 Chalkstone Ave., Bldg 32, Providence, RI, 02908, USA ARTICLE INFO ABSTRACT Keywords: Obsessive-compulsive disorder (OCD), a leading cause of disability, affects ~1–2% of the population, and can be Obsessive-compulsive disorder distressing and disabling. About 1/3 of individuals demonstrate poor responsiveness to conventional treatments. Deep brain stimulation A small proportion of these individuals may be deep brain stimulation (DBS) candidates. Candidacy is assessed Neurosurgery through a multidisciplinary process including assessment of illness severity, chronicity, and functional impact. Psychiatry Optimization failure, despite multiple treatments, is critical during screening. Few patients nationwide are eligible for OCD DBS and thus a multi-center approach was necessary to obtain adequate sample size. The study * Corresponding author. Alpert Medical School of Brown University Butler Hospital, 345 Blackstone Blvd. Providence, RI, 02906, USA. E-mail address: [email protected] (N.C.R. McLaughlin). 1 Department of Neurological Surgery, Montefiore Medical Center, 3316 Rochambeau Ave, Bronx, NY 10467. 2 Albert Einstein College of Medicine, 1300 Morris Park Ave, The Bronx, NY 10461. 3 Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd., Houston, TX 77030. 4 Mcguire Translational Research Facility 3–208, University of Minnesota, 2001 6th St SE, Minneapolis, MN 55455. 5 Weill Cornell-Rockefeller-Sloan Kettering Tri-Institutional MD-PhD Program, 420 E 70th St, New York, NY 10021. https://doi.org/10.1016/j.conctc.2021.100785 Received 9 October 2020; Received in revised form 14 April 2021; Accepted 16 May 2021 Available online 5 June 2021 2451-8654/© 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). N.C.R. McLaughlin et al. Contemporary Clinical Trials Communications 22 (2021) 100785 was conducted over a six-year period and was a NIH-funded, eight-center sham-controlled trial of DBS targeting the ventral capsule/ventral striatum (VC/VS) region. There were 269 individuals who initially contacted the sites, in order to achieve 27 participants enrolled. Study enrollment required extensive review for eligibility, which was overseen by an independent advisory board. Disabling OCD had to be persistent for ≥5 years despite exhaustive medication and behavioral treatment. The final cohort was derived from a detailed consent process that included consent monitoring. Mean illness duration was 27.2 years. OCD symptom subtypes and psychiatric comorbidities varied, but all had severe disability with impaired quality of life and functioning. Participants were randomized to receive sham or active DBS for three months. Following this period, all participants received active DBS. Treatment assignment was masked to participants and raters and assessments were blinded. The final sample was consistent in demographic characteristics and clinical features when compared to other contempo­ rary published prospective studies of OCD DBS. We report the clinical trial design, methods, and general de­ mographics of this OCD DBS sample. 1. Introduction OCD research. Due to recruiting difficulties given the stringent entry criteria, we expanded progressively, adding Massachusetts General Obsessive-compulsive disorder (OCD) is a leading cause of disability in Hospital (MGH), George Washington University (GW), Wake Forest, developed countries, with a one-year prevalence of about 1% [1]. It is Mount Sinai, Kaiser Permanente, University of Chicago, and Mayo characterized by distressing and highly disabling intrusive, Clinic. All sites either had or developed teams with appropriate expertise anxiety-provoking obsessions and compulsive rituals. About a third of in DBS for OCD. Two sites, University of Chicago and Wake Forest, ul­ affected individuals are poorly responsive to medication or behavioral timately did not implant patients. Several factors slowed the pace of therapies [2–5]. A much smaller proportion, including those with the patient recruitment but the primary factor was the relative rarity of the greatest illness severity, chronicity, and functional impact despite optimized target population (estimated at under 1% of treatment-seeking OCD behavioral and medication treatments, might be candidates for either patients [8]). A second limiting factor was ensuring that prospective ablation or deep brain stimulation (DBS; [6–8,66]. surgical candidates had appropriate U.S. insurance coverage that made Stereotactic surgeries for OCD developed empirically in the mid-20th ongoing, and in fact indefinite, access to this intensive treatment after century and targeted nodes within fronto-basal networks. Subsequent the trial highly likely in case it proved effective for them. In many cases functional neuroimaging studies in patients with OCD illustrated the this required a formal petition to a regional insurance carrier which importance of these networks [9]; thereby providing support for the varied by site. The majority of the participants had US Medicare by surgical targets. DBS for OCD was introduced by Nuttin and colleagues virtue of disability due to OCD. Relevant approvals including an [10] in Europe. Nuttin’s DBS target was initially based on anterior Investigator-Sponsored Investigational Device Exemption (IDE capsulotomy, arguably the most effective ablation. G070235/R006) from the U.S. FDA and IRB approvals centrally (at Deep brain stimulation for OCD was first used in the United States Butler Hospital) and at each local site (NCT00640133) required signif­ several years later [11,12]. As with lesion procedures, selection criteria icant time and effort to move through the appropriate processes. In are strict (see Methods): candidates must have severe, chronic, and addition, Kaiser Permanente had to seek state approval through the otherwise intractable illness. Sustained and optimized medication and county mental health department, and were the first in their state
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