Myths and facts about the EARLYSTIM study

Movement Disorders

Volumn 29, Issue 14, 2014, Pages 1742-1750

  Schüpbach, W M Michael ^a,b   Rau, Jörn ^c   Houeto, Jean Luc ^d   Krack, Paul ^e   Schnitzler, Alfons ^f   Schade Brittinger, Carmen ^c   Timmermann, Lars ^g   Deuschl, Günther ^h  

^a ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^b UNIVERSITY OF BERN   (Switzerland)

^c PHILIPPS UNIVERSITY MARBURG   (Germany)

^d UNIVERSITÉ DE POITIERS   (France)

^e GRENOBLE UNIVERSITY HOSPITAL   (France)

^f HEINRICH HEINE UNIVERSITY   (Germany)

^g UNIVERSITY OF COLOGNE   (Germany)

^h UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

Author keywords

Deep brain stimulation; EARLYSTIM study; Parkinson's disease; Placebo effect; Subthalamic nucleus

Indexed keywords

ARTICLE; BRAIN DEPTH STIMULATION; CONTROLLED CLINICAL TRIAL (TOPIC); DISABILITY; DISEASE COURSE; ELECTRODE; FOLLOW UP; HUMAN; IMPLANTATION; OUTCOME ASSESSMENT; PARKINSON DISEASE; PARKINSONISM; PLACEBO EFFECT; SUBTHALAMIC NUCLEUS; SUICIDAL BEHAVIOR; MOVEMENT (PHYSIOLOGY); PATHOPHYSIOLOGY; PHYSIOLOGY; QUALITY OF LIFE;

DEEP BRAIN STIMULATION; HUMANS; MOVEMENT; PARKINSON DISEASE; PLACEBO EFFECT; QUALITY OF LIFE; SUBTHALAMIC NUCLEUS;

EID: 84918816785     PISSN: 08853185     EISSN: 15318257     Source Type: Journal    
DOI: 10.1002/mds.26080     Document Type: Article

References (32)

1. Deuschl G, Agid Y. Subthalamic neurostimulation for Parkinson's disease with early fluctuations: balancing the risks and benefits. Lancet Neurol 2013;12:1025-1034.
2. Schupbach WM, Maltete D, Houeto JL, et al. Neurosurgery at an earlier stage of Parkinson disease: a randomized, controlled trial. Neurology 2007;68:267-271.
3. Schuepbach WM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med 2013;368:610-622.
4. Deuschl G, Schade-Brittinger C, Krack P, et al. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med 2006;355:896-908.
5. Deuschl G, Schupbach M, Knudsen K, et al. Stimulation of the subthalamic nucleus at an earlier disease stage of Parkinson's disease: concept and standards of the EARLYSTIM-study. Parkinsonism Relat Disord 2013;19:56-61.
6. Tanner CM. A second honeymoon for Parkinson's disease? N Engl J Med 2013;368:675-676.
7. Martinez-Martin P, Deuschl G. Effect of medical and surgical interventions on health-related quality of life in Parkinson's disease. Mov Disord 2007;22:757-765.
8. Goetz CG, Wuu J, McDermott MP, et al. Placebo response in Parkinson's disease: comparisons among 11 trials covering medical and surgical interventions. Mov Disord 2008;23:690-699.
9. McRae C, Cherin E, Yamazaki TG, et al. Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry 2004;61:412-420.
10. Eberling JL, Jagust WJ, Christine CW, et al. Results from a phase I safety trial of hAADC gene therapy for Parkinson disease. Neurology 2008;70:1980-1983.
11. Kaplitt MG, Feigin A, Tang C, et al. Safety and tolerability of gene therapy with an adeno-associated virus (AAV) borne GAD gene for Parkinson's disease: an open label, phase I trial. Lancet 2007;369:2097-2105.
12. Goetz CG, Leurgans S, Raman R, Stebbins GT. Objective changes in motor function during placebo treatment in PD. Neurology. 2000;54:710-714.
13. Yelnik J. Functional anatomy of the basal ganglia. Mov Disord 2002;17(Suppl 3):S15-S21.
14. Hassler R, Mundinger F, Riechert T. Stereotaxis in Parkinson Syndrome: Clinical-Anatomical Contributions to Its Physiology, With an Atlas of the Basal Ganglia in Parkinsonism. Berlin, Heidelberg, New York: Springer Verlag; 1979.
15. Maltete D, Chastan N, Derrey S, et al. Microsubthalamotomy effect at day 3: screening for determinants. Mov Disord 2009;24:286-289.
16. Okun MS, Gallo BV, Mandybur G, et al. Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial. Lancet Neurol 2012;11:140-149.
17. DBSfPD Study Group. Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med 2001;345:956-963.
18. de la Fuente-Fernandez R. Uncovering the hidden placebo effect in deep-brain stimulation for Parkinson's disease. Parkinsonism Relat Disord 2004;10:125-127.
19. Temperli P, Ghika J, Villemure JG, Burkhard PR, Bogousslavsky J, Vingerhoets FJ. How do parkinsonian signs return after discontinuation of subthalamic DBS? Neurology 2003;60:78-81.
20. Wider C, Russmann H, Villemure JG, et al. Long-duration response to levodopa in patients with advanced Parkinson disease treated with subthalamic deep brain stimulation. Arch Neurol 2006;63:951-955.
21. Krack P, Batir A, Van Blercom N, et al. Five-year follow-up of bilateral stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med 2003;349:1925-1934.
22. Maetzler W, Liepelt I, Berg D. Progression of Parkinson's disease in the clinical phase: potential markers. Lancet Neurol 2009;8:1158-1171.
23. Sinyor M, Levitt AJ, Cheung AH, et al. Does inclusion of a placebo arm influence response to active antidepressant treatment in randomized controlled trials? Results from pooled and meta-analyses. J Clin Psychiatry 2010;71:270-279.
24. Woods SW, Gueorguieva RV, Baker CB, Makuch RW. Control group bias in randomized atypical antipsychotic medication trials for schizophrenia. Arch Gen Psychiatry 2005;62:961-970.
25. Mestre TA, Shah P, Marras C, Tomlinson G, Lang AE. Another face of placebo: the lessebo effect in Parkinson disease: meta-analyses. Neurology 2014;82:1402-1409.
26. Schrag A, Sampaio C, Counsell N, Poewe W. Minimal clinically important change on the unified Parkinson's disease rating scale. Mov Disord 2006;21:1200-1207.
27. Jankovic J, Kapadia AS. Functional decline in Parkinson disease. Arch Neurol 2001;58:1611-1615.
28. Louis ED, Tang MX, Cote L, Alfaro B, Mejia H, Marder K. Progression of parkinsonian signs in Parkinson disease. Arch Neurol 1999;56:334-337.
29. Eggers C, Pedrosa DJ, Kahraman D, et al. Parkinson subtypes progress differently in clinical course and imaging pattern. PLoS One 2012;7:e46813.
30. Horstink M, Tolosa E, Bonuccelli U, et al. Review of the therapeutic management of Parkinson's disease. Report of a joint task force of the European Federation of Neurological Societies (EFNS) and the Movement Disorder Society-European Section (MDS-ES). Part II: late (complicated) Parkinson's disease. Eur J Neurol 2006;13:1186-1202.
31. Hughes AJ, Daniel SE, Ben-Shlomo Y, Lees AJ. The accuracy of diagnosis of parkinsonian syndromes in a specialist movement disorder service. Brain 2002;125:861-870.
32. Charles D, Konrad PE, Neimat JS, et al. Subthalamic nucleus deep brain stimulation in early stage Parkinson's disease. Parkinsonism Relat Disord 2014;20(7):731-737.