Contemporary Clinical Trials Communications (Jun 2021)
Double blind randomized controlled trial of deep brain stimulation for obsessive-compulsive disorder: Clinical trial design
- Nicole C.R. McLaughlin,
- Darin D. Dougherty,
- Emad Eskandar,
- Herbert Ward,
- Kelly D. Foote,
- Donald A. Malone,
- Andre Machado,
- William Wong,
- Mark Sedrak,
- Wayne Goodman,
- Brian H. Kopell,
- Fuad Issa,
- Donald C. Shields,
- Osama A. Abulseoud,
- Kendall Lee,
- Mark A. Frye,
- Alik S. Widge,
- Thilo Deckersbach,
- Michael S. Okun,
- Dawn Bowers,
- Russell M. Bauer,
- Dana Mason,
- Cynthia S. Kubu,
- Ivan Bernstein,
- Kyle Lapidus,
- David L. Rosenthal,
- Robert L. Jenkins,
- Cynthia Read,
- Paul F. Malloy,
- Stephen Salloway,
- David R. Strong,
- Richard N. Jones,
- Steven A. Rasmussen,
- Benjamin D. Greenberg
Affiliations
- Nicole C.R. McLaughlin
- Butler Hospital, 345 Blackstone Blvd, Providence, RI, 02906, USA; Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA; Corresponding author. Alpert Medical School of Brown University Butler Hospital, 345 Blackstone Blvd. Providence, RI, 02906, USA.
- Darin D. Dougherty
- Massachusetts General Hospital, 149 13th Street; Charlestown, MA, 02129, USA; Harvard Medical School, 25 Shattuck St., Boston, MA, 02115, USA
- Emad Eskandar
- Massachusetts General Hospital, 149 13th Street; Charlestown, MA, 02129, USA; Harvard Medical School, 25 Shattuck St., Boston, MA, 02115, USA
- Herbert Ward
- Department of Psychiatry, UF Health Springhill, University of Florida, 4037 NW 86th Terrace, Gainesville, FL, 32606, USA
- Kelly D. Foote
- Norman Fixel Institute of Neurological Diseases, Department of Neurology, University of Florida, 3009 SW Williston Dr., Gainesville, FL, 32608, USA
- Donald A. Malone
- Cleveland Clinic Neurological Institute, 9500 Euclid Ave., Cleveland, OH, 44195, USA
- Andre Machado
- Cleveland Clinic Neurological Institute, 9500 Euclid Ave., Cleveland, OH, 44195, USA
- William Wong
- Kaiser Permanente, 1100 Veterans Blvd., Redwood City, CA, 94063, USA
- Mark Sedrak
- Kaiser Permanente, Department of Neurosurgery, 1150 Veterans Blvd., Redwood City, CA, 94063, USA
- Wayne Goodman
- Department of Psychiatry, Icahn School of Medicine at Mount Sinai, 1000 10th Avenue, New York, NY, 10011, USA
- Brian H. Kopell
- Department of Psychiatry, Icahn School of Medicine at Mount Sinai, 1000 10th Avenue, New York, NY, 10011, USA
- Fuad Issa
- Department of Psychiatry & Behavioral Sciences, School of Medicine & Health Sciences, George Washington University, 2120 L Street, NW, Suite 600, Washington, DC, 20037, USA
- Donald C. Shields
- Department of Neurosurgery, The George Washington University, 2150 Pennsylvania Ave., NW, Ste. 7-409 Washington, DC, 20037, USA
- Osama A. Abulseoud
- Neuroimaging Research Branch at the National Institute on Drug Abuse, 251 Bayview Boulevard, Baltimore, MD, 21224, USA
- Kendall Lee
- Mayo Clinic College of Medicine, 200 First Street SW, Rochester MN, 55901, USA
- Mark A. Frye
- Mayo Clinic College of Medicine, 200 First Street SW, Rochester MN, 55901, USA
- Alik S. Widge
- Massachusetts General Hospital, 149 13th Street; Charlestown, MA, 02129, USA; Harvard Medical School, 25 Shattuck St., Boston, MA, 02115, USA; Massachusetts Institute of Technology, 77 Massachusetts Ave, Cambridge, MA, 02139, USA
- Thilo Deckersbach
- University of Applied Sciences Europe, Dessauer Str. 3-5, 10963, Berlin, Germany
- Michael S. Okun
- Norman Fixel Institute of Neurological Diseases, Department of Neurology, University of Florida, 3009 SW Williston Dr., Gainesville, FL, 32608, USA
- Dawn Bowers
- Department of Clinical & Health Psychology, University of Florida, PO Box 100165, Gainesville, FL, 32610, USA
- Russell M. Bauer
- Department of Clinical & Health Psychology, University of Florida, PO Box 100165, Gainesville, FL, 32610, USA
- Dana Mason
- Department of Psychiatry, UF Health Springhill, University of Florida, 4037 NW 86th Terrace, Gainesville, FL, 32606, USA
- Cynthia S. Kubu
- Cleveland Clinic Neurological Institute, 9500 Euclid Ave., Cleveland, OH, 44195, USA
- Ivan Bernstein
- Kaiser Permanente, 1100 Veterans Blvd., Redwood City, CA, 94063, USA
- Kyle Lapidus
- Northwell Health, 300 West 72 Street, #1D, New York, NY, 10023, USA
- David L. Rosenthal
- Department of Psychiatry, Icahn School of Medicine at Mount Sinai, 1000 10th Avenue, New York, NY, 10011, USA
- Robert L. Jenkins
- Department of Psychiatry & Behavioral Sciences, School of Medicine & Health Sciences, George Washington University, 2120 L Street, NW, Suite 600, Washington, DC, 20037, USA
- Cynthia Read
- Butler Hospital, 345 Blackstone Blvd, Providence, RI, 02906, USA
- Paul F. Malloy
- Butler Hospital, 345 Blackstone Blvd, Providence, RI, 02906, USA; Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA
- Stephen Salloway
- Butler Hospital, 345 Blackstone Blvd, Providence, RI, 02906, USA; Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA
- David R. Strong
- Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, La Jolla, Ca, 92093, USA
- Richard N. Jones
- Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA
- Steven A. Rasmussen
- Butler Hospital, 345 Blackstone Blvd, Providence, RI, 02906, USA; Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA
- Benjamin D. Greenberg
- Butler Hospital, 345 Blackstone Blvd, Providence, RI, 02906, USA; Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, Providence, RI, USA; Center for Neurorestoration & Neurotechnology, Providence VA Medical Center, 830 Chalkstone Ave., Bldg 32, Providence, RI, 02908, USA
- Journal volume & issue
-
Vol. 22
p. 100785
Abstract
Obsessive-compulsive disorder (OCD), a leading cause of disability, affects ~1–2% of the population, and can be distressing and disabling. About 1/3 of individuals demonstrate poor responsiveness to conventional treatments. A small proportion of these individuals may be deep brain stimulation (DBS) candidates. Candidacy is assessed through a multidisciplinary process including assessment of illness severity, chronicity, and functional impact. 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 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 contemporary published prospective studies of OCD DBS. We report the clinical trial design, methods, and general demographics of this OCD DBS sample.
