Electrical brain stimulation for psychiatric disorders Bart Nuttin, Loes Gabriëls Disclosure • Medtronic is providing grants for research, education and traveling • Patent : DBS in OCD • Grants : OT, FWO, IWT, SBO • K.U. Leuven : Gabriëls, van Kuyck, Welkenhuysen, Luyten, Ahmed, • • Prodanov, Van Laere, Dupont, Sunaert, Demeulemeester, Gybels, Tousseyn, Dewil, Vandenbroeck, Brak, Das, Arckens, Nuttin. Universiteit Antwerpen : Cosyns, Neefs, Vankerckhoven, Cluydts, … Karolinska : Meyerson, Linderoth, Andréewitch, Mindus, Rück, … • • • • • Brown University : Friehs, Rasmussen, Greenberg, … Cleveland Clinic : Rezai, Malone, … Köln : Sturm, Klosterkötter, … University of Michigan : Curtis, Abelson, … Orlando : Goodman, Okun, Foot, … • Amsterdam – Utrecht : Bosch, Schuurman, … • Grenoble : Benabid, … • Medtronic Inc. : Mullett, Gielen, Rise, Stypulkowski, Langevin, … Electrical stimulation for psychiatric disorders Electrical brain stimulation may change behavior, cognition and mood High standards for research in this field DBS in psychiatric disorders Neurosurgical Clinics of North America, 14: XV-XVI, 2003 A patient assessment committee should evaluate each patient Acceptability of capsulotomy and DBS for OCD • 84 psychiatrists questioned • 73 (87%) completed anonymous questionnaire Requirements for the decision for capsulotomy or DBS neurosurgeon + pt 0% + neurosurgeon + pt 3% committee + + neurosurgeon + pt 97% Europäische Akademie zur Erforschung von Folgen wissenschaftlich-technischer Entwicklungen Bad Neuenahr-Ahrweiler GmbH Merckel R, Boer G, Galert T, Fegert J, Hartman D, Nuttin B, Rosahl S Intervening in the Brain Changing Psyche and Society (Springer Verlag, 2007) Recommendations Treatment patient reimbursement Prevention patient / normal reimbursement person Enhancement normal person no reimbursement Treatment patient reimbursement Prevention patient / normal reimbursement person Enhancement normal person no reimbursement Treatment of psychiatric patients with DBS remains investigational and is NOT considered standard therapy. Treatment of psychiatric patients with DBS remains investigational and is NOT considered standard therapy. FDA 2009 : Humanitarian device exemption (HDE) for DBS in OCD In Europe (2009) : CE-mark Treatment of psychiatric patients with DBS remains investigational and is NOT considered standard therapy. FDA 2009 : Humanitarian device exemption (HDE) for DBS in OCD HDE is only temporary solution To make DBS for OCD a “therapy”, one needs at least 2 clinical trials with class A evidence Europäische Akademie zur Erforschung von Folgen wissenschaftlich-technischer Entwicklungen Bad Neuenahr-Ahrweiler GmbH J. Fins, T. Schlaepfer, B. Nuttin, C. Kubu, T. Galert, V. Sturm, R. Merkel, H. Mayberg DBS for OCD in Belgium • Physician sponsored study : 24 patients, double blind randomized cross-over, 1001 patient months follow-up • Medtronic descriptive follow-up : multicenter, in Europe (for CE mark) Inclusion criteria • Diagnosis of OCD by Structural Clinical Interview (DSM-IV, SCID-IV) • Y-BOCS at least 30/40 • GAF ≤ 45 • This level of impairment must have persisted for a minimum of 5 years, despite adequate trials or intolerance to 2 or 3 SSRIs and clomipramine, augmentation strategies (antipsychotics) and CBT Inclusion criteria • At least 18y, no more than 60y of age • Must be able to understand, comply with instructions and provide own written informed consent Exclusion criteria • A current or past psychotic disorder • Any clinically significant disorder or medical illness affecting brain function or structure (other than motor tics or Gilles de la Tourette syndrome) • Current or unstably remitted substance abuse BEFORE IMPLANT AFTER IMPLANT Electrodes Bed nucleus of stria terminalis Anterior limb of internal capsule Anterior commissure 3 lv t 2 f/s 1 ac 0 bm bc bl bc g III oc bv m db 26 patients : - Leuven/Antwerp Brown University, Providence Cleveland Clinic, Ohio Orlando Research into DBS for therapyrefractory psychiatric disorders Multiple targets : Anterior limb of internal capsule, NACC, BST, STN, caudate nucleus, … Multiple indications : OCD, major depression, anxiety disorders, eating disorders, … Many centers are performing this research But NOT YET A REAL THERAPY ! Research into DBS for therapyrefractory psychiatric disorders Multiple targets : Anterior limb of internal capsule, NACC, BST, STN, caudate nucleus, … Multiple indications : OCD, major depression, anxiety disorders, eating disorders, … Many centers are performing this research But NOT YET A REAL THERAPY ! Conclusions for DBS in psychiatric disorders • Some evidence : case reports, some randomized controlled cross-over studies, longterm follow-up • OCD = most close to a therapy but not a therapy yet • At this moment safety is comparable with safety of DBS for PD • It has not been shown that it is better than lesions (e.g. anterior capsulotomy) . Thank you