Bart Nuttin - the North American Neuromodulation Society

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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
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