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.
- electrical stimulation
- stereotaxic surgery
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AAB and CBM contributed equally.
Contributors AAB, CBM, JSN, NP and SAS collated the minutes into the final manuscript. All other authors participated in discussions about psychiatric neurosurgery and/or commented on the final manuscript.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
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.
Provenance and peer review Not commissioned; externally peer reviewed.
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