Charting the road forward in psychiatric neurosurgery: proceedings of the 2016 American Society for Stereotactic and Functional Neurosurgery workshop on neuromodulation for psychiatric disorders

Ausaf A Bari^#¹, Charles B Mikell^#², Aviva Abosch³, Sharona Ben-Haim⁴, Robert J Buchanan⁵, Allen W Burton⁶, Stephen Carcieri⁷, G Rees Cosgrove⁸, Pierre-Francois D'Haese⁹, Zafiris Jeffrey Daskalakis¹⁰, Emad N Eskandar¹¹, Jason L Gerrard¹², Wayne K Goodman¹³, Benjamin David Greenberg¹⁴, Robert E Gross¹⁵, Clement Hamani¹⁶, Zelma H T Kiss¹⁷, Peter Konrad¹⁸, Brian H Kopell¹⁹, Lothar Krinke²⁰, Jean-Philippe Langevin¹, Andres M Lozano¹⁶, Donald Malone²¹, Helen S Mayberg²², Jonathan P Miller²³, Parag G Patil²⁴, DeLea Peichel⁶, Erika A Petersen²⁵, Ali R Rezai²⁶, R Mark Richardson²⁷, Patricio Riva-Posse²², Tejas Sankar²⁸, Jason M Schwalb²⁹, Helen Blair Simpson³⁰, Konstantin Slavin³¹, Paul H Stypulkowski²⁰, Tor Tosteson³², Peter Warnke³³, Jon T Willie¹⁵, Kareem A Zaghloul³⁴, Joseph S Neimat³⁵, Nader Pouratian¹, Sameer A Sheth³⁶

Affiliations

¹ Department of Neurosurgery, University of California Los Angeles Medical Center, Los Angeles, California, USA.
² Department of Neurosurgery, Stony Brook University Hospital, Stony Brook, New York, USA.
³ Department of Neurosurgery, School of Medicine, University of Colorado, Aurora, Colorado, USA.
⁴ Department of Neurosurgery, University of California San Diego Health, La Jolla, California, USA.
⁵ Department of Neurosurgery, Seton Brain and Spine Institute, Austin, Texas, USA.
⁶ Neuromodulation, Movement Disorders, and Pain, St. Jude-Abbott, Plano, Texas, USA.
⁷ Neuromodulation, Boston Scientific Corp, Marlborough, Massachusetts, USA.
⁸ Department of Neurosurgery, Brigham and Women's Hospital, Boston, Massachusetts, USA.
⁹ School of Engineering, Vanderbilt University, Nashville, Tennessee, USA.
¹⁰ Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
¹¹ Department of Neurosurgery, Albert Einstein College of Medicine, Bronx, NY, USA.
¹² Department of Neurosurgery, Yale University School of Medicine, New Haven, Connecticut, USA.
¹³ Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas, USA.
¹⁴ Department of Psychiatry and Human Behavior, Brown University, Providence, Rhode Island, USA.
¹⁵ Department of Neurosurgery, Emory University, Atlanta, Georgia, USA.
¹⁶ Division of Neurosurgery, University of Toronto, Toronto, Ontario, Canada.
¹⁷ Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.
¹⁸ Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
¹⁹ Department of Neurosurgery, The Mount Sinai Hospital, New York City, New York, USA.
²⁰ Medtronic Neuromodulation, Minneapolis, Minnesota, USA.
²¹ Department of Psychiatry and Psychology, Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA.
²² Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.
²³ Department of Neurological Surgery, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
²⁴ Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan, USA.
²⁵ Department of Neurosurgery, University of Arkansas for Medical Science, Little Rock, Arkansas, USA.
²⁶ Neurological Institute, Ohio State University, Columbus, Ohio, USA.
²⁷ Department of Neurosurgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
²⁸ Division of Neurosurgery, University of Alberta, Edmonton, Alberta, Canada.
²⁹ Department of Neurosurgery, Henry Ford Health System, Detroit, Michigan, USA.
³⁰ Department of Psychiatry, Columbia University, NY State Psychiatric Institute, New York, NY.
³¹ Department of Neurosurgery, University of Illinois College of Medicine, Chicago, Illinois, USA.
³² Departmentof Biomedical Data Science, Geisel School of Medicine, Dartmouth University, Hanover, New Hampshire, USA.
³³ Section of Neurosurgery, Department of Surgery, University of Chicago, Chicago, Illinois, USA.
³⁴ Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland, USA.
³⁵ Department of Neurosurgery, University of Louisville, Louisville, Kentucky, USA.
³⁶ Department of Neurosurgery, Baylor College of Medicine, Houston, TX, USA.

^# Contributed equally.

PMID: 29371415
PMCID: PMC7340367
DOI: 10.1136/jnnp-2017-317082

Charting the road forward in psychiatric neurosurgery: proceedings of the 2016 American Society for Stereotactic and Functional Neurosurgery workshop on neuromodulation for psychiatric disorders

Ausaf A Bari et al. J Neurol Neurosurg Psychiatry. 2018 Aug.

. 2018 Aug;89(8):886-896.

doi: 10.1136/jnnp-2017-317082. Epub 2018 Jan 25.

Authors

Affiliations

¹ Department of Neurosurgery, University of California Los Angeles Medical Center, Los Angeles, California, USA.
² Department of Neurosurgery, Stony Brook University Hospital, Stony Brook, New York, USA.
³ Department of Neurosurgery, School of Medicine, University of Colorado, Aurora, Colorado, USA.
⁴ Department of Neurosurgery, University of California San Diego Health, La Jolla, California, USA.
⁵ Department of Neurosurgery, Seton Brain and Spine Institute, Austin, Texas, USA.
⁶ Neuromodulation, Movement Disorders, and Pain, St. Jude-Abbott, Plano, Texas, USA.
⁷ Neuromodulation, Boston Scientific Corp, Marlborough, Massachusetts, USA.
⁸ Department of Neurosurgery, Brigham and Women's Hospital, Boston, Massachusetts, USA.
⁹ School of Engineering, Vanderbilt University, Nashville, Tennessee, USA.
¹⁰ Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
¹¹ Department of Neurosurgery, Albert Einstein College of Medicine, Bronx, NY, USA.
¹² Department of Neurosurgery, Yale University School of Medicine, New Haven, Connecticut, USA.
¹³ Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas, USA.
¹⁴ Department of Psychiatry and Human Behavior, Brown University, Providence, Rhode Island, USA.
¹⁵ Department of Neurosurgery, Emory University, Atlanta, Georgia, USA.
¹⁶ Division of Neurosurgery, University of Toronto, Toronto, Ontario, Canada.
¹⁷ Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada.
¹⁸ Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
¹⁹ Department of Neurosurgery, The Mount Sinai Hospital, New York City, New York, USA.
²⁰ Medtronic Neuromodulation, Minneapolis, Minnesota, USA.
²¹ Department of Psychiatry and Psychology, Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA.
²² Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.
²³ Department of Neurological Surgery, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
²⁴ Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan, USA.
²⁵ Department of Neurosurgery, University of Arkansas for Medical Science, Little Rock, Arkansas, USA.
²⁶ Neurological Institute, Ohio State University, Columbus, Ohio, USA.
²⁷ Department of Neurosurgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
²⁸ Division of Neurosurgery, University of Alberta, Edmonton, Alberta, Canada.
²⁹ Department of Neurosurgery, Henry Ford Health System, Detroit, Michigan, USA.
³⁰ Department of Psychiatry, Columbia University, NY State Psychiatric Institute, New York, NY.
³¹ Department of Neurosurgery, University of Illinois College of Medicine, Chicago, Illinois, USA.
³² Departmentof Biomedical Data Science, Geisel School of Medicine, Dartmouth University, Hanover, New Hampshire, USA.
³³ Section of Neurosurgery, Department of Surgery, University of Chicago, Chicago, Illinois, USA.
³⁴ Surgical Neurology Branch, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland, USA.
³⁵ Department of Neurosurgery, University of Louisville, Louisville, Kentucky, USA.
³⁶ Department of Neurosurgery, Baylor College of Medicine, Houston, TX, USA.

^# Contributed equally.

PMID: 29371415
PMCID: PMC7340367
DOI: 10.1136/jnnp-2017-317082

Abstract

Objective: Refractory psychiatric disease is a major cause of morbidity and mortality worldwide, and there is a great need for new treatments. In the last decade, investigators piloted novel deep brain stimulation (DBS)-based therapies for depression and obsessive-compulsive disorder (OCD). Results from recent pivotal trials of these therapies, however, did not demonstrate the degree of efficacy expected from previous smaller trials. To discuss next steps, neurosurgeons, neurologists, psychiatrists and representatives from industry convened a workshop sponsored by the American Society for Stereotactic and Functional Neurosurgery in Chicago, Illinois, in June of 2016.

Design: Here we summarise the proceedings of the workshop. Participants discussed a number of issues of importance to the community. First, we discussed how to interpret results from the recent pivotal trials of DBS for OCD and depression. We then reviewed what can be learnt from lesions and closed-loop neurostimulation. Subsequently, representatives from the National Institutes of Health, the Food and Drug Administration and industry discussed their views on neuromodulation for psychiatric disorders. In particular, these third parties discussed their criteria for moving forward with new trials. Finally, we discussed the best way of confirming safety and efficacy of these therapies, including registries and clinical trial design. We close by discussing next steps in the journey to new neuromodulatory therapies for these devastating illnesses.

Conclusion: Interest and motivation remain strong for deep brain stimulation for psychiatric disease. Progress will require coordinated efforts by all stakeholders.

Keywords: depression; electrical stimulation; psychiatry; stereotaxic surgery.

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Conflict of interest statement

Competing interests: AA reports grants from Alpha Omega outside the submitted work. The period of funding was completed prior to publication of this manuscript. AWB reports employment from Abbott during the conduct of the study. SC reports employment from Boston Scientific during the conduct of the study. P-FD reports personal fees from Neurotargeting LLC outside the submitted work. ZJD reports other from Magventure, grants from Brainsway NIMH, Brain Canada, OMHF, CIHR and other from Temerty Family Foundation and Grant Family Foundation outside the submitted work. JLG reports personal fees from Medtronic outside the submitted work. WKG reports grants from NIH, Simons Foundation and Biohaven and other from Medtronic during the conduct of the study. BDG has nothing to disclose. He is supported by VA RR&D Center for Neurorestoration and Neurotechnology, N9228-C, PVAMC. REG is a consultant for Abbott (previously St Jude Medical), Medtronic, MRI Interventions, SanBio, Neuralstem, Monteris, Neuropace and Zimmer-Biomet. He has received grant support from NIH, DARPA, NSF, Michael J Fox, CURE, American Epilepsy Society, Neuropace, Medtronic, SanBio, MRI Interventions and Boston Scientific. CH reports honoraria from St Jude Medical and Medtronic. ZHTK reports grants from Alberta Innovates Health Solutions CRIO grant during the conduct of the study. BHK reports personal fees from Medtronic and Abbott Neuromodulation outside the submitted work. LK reports employment from Medtronic during the conduct of the study. He is currently an employee of Magstim. J-PL has nothing to disclose, except he has a patent US 20120290058 A1 pending. AML reports personal fees from Medtronic, St. Jude, Boston Scientific and other from Functional Neuromodulation outside the submitted work. DM reports grants from Medtronic outside the submitted work. HSM reports grants from Hope for Depression Research Foundation, grants from NIMH, non-financial support from St Jude Medical Inc and Medtronic and other from St Jude Medical Inc outside the submitted work. In addition, she has a patent US2005/0033379A1 licenced to St Jude Medical Inc. DP reports employment from Abbott during the conduct of the study. EAP reports grants and personal fees from Medtronic Inc and St. Jude Neuromodulation (Abbott) and grants and personal fees from Boston Scientific Neuromodulation outside the submitted work. AR reports other from Autonomic Technologies, Inc and other from Neurotechnology Innovations Translator and Neurotechnology Innovations Management outside the submitted work. RMR reports grants from Medtronic, Inc outside the submitted work. PR-P reports personal fees from Johnson & Johnson outside the submitted work. JMS reports grants from Medtronic and Boston Scientific outside the submitted work. HBS reports royalties from UpToDate, Inc and Cambridge University Press. KS reports and discloses past work as a consultant for device manufacturing companies Medtronic, Abbott (formerly St. Jude Medical), Boston Scientific, Nuvectra, Nevro and Stimwave. PHS reports employment from Medtronic during the conduct of the study. JTW discloses consulting/teaching for Medtronic, Inc, MRI Interventions, Inc and NICO Corporation. JSN reports personal fees from St Jude/Abbott Inc during the conduct of the study. NP reports grants from Medtronic and Abbott, grants and personal fees from BrainLab and Second Sight Medical Products and personal fees from Boston Scientific outside the submitted work. In addition, NP has a patent A Method for Deep Brain Stimulation Targeting issued. SAS reports consulting fees from Boston Scientific and Medtronic.

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Charting the road forward in psychiatric neurosurgery: proceedings of the 2016 American Society for Stereotactic and Functional Neurosurgery workshop on neuromodulation for psychiatric disorders

Affiliations

Charting the road forward in psychiatric neurosurgery: proceedings of the 2016 American Society for Stereotactic and Functional Neurosurgery workshop on neuromodulation for psychiatric disorders

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical