Controlled Trial of Deep Brain Stimulation in Early Patients With Parkinson's Disease

Tracking Information
First Submitted Date ICMJE	July 19, 2006
First Posted Date ICMJE	July 20, 2006
Last Update Posted Date	January 31, 2012
Study Start Date ICMJE	July 2006
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 26, 2008)	Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment. [ Time Frame: 24 months ]
Original Primary Outcome Measures ICMJE; (submitted: July 19, 2006)	Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment.
Change History	Complete list of historical versions of study NCT00354133 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 16, 2010)	Change in the Unified Parkinson's disease Rating Scale (UPDRS) part III, Change in the number of hours per day in the "best"-state,Frequency and severity of "best"state dyskinesias,Sleeping-hours per day,Changes in gait and speech, [ Time Frame: 24 months ]; UPDRS II and VI, SCOPA-PS, BDI, MADRS, BPRS, Mattis Dementia Scale,Ardouin Behaviour Scale, Starkstein-Apathy Scale, professional fitness, SF-36,pain (VAS), clinical global impression (CGI-GI) [ Time Frame: 24 months ]; Frequency, type and severity of therapy related adverse events of medication or DBS, Change in medication (L-DOPA equivalents) [ Time Frame: 24 months ]
Original Secondary Outcome Measures ICMJE; (submitted: July 19, 2006)	UPDRS part III(medication-off and on-state), hours per day in the "best ON", Frequency and severity of ON-dyskinesia, Sleeping hours, Gait and speech; UPDRS II, SCOPA-PS, BDI, MADRS, BPRS, Mattis Dementia Scale, Starkstein-Apathy Scale, professional fitness, SF-36,pain (VAS), clinical global impression (CGI-GI); Frequency, type and severity of therapy related adverse events of medication or DBS
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Controlled Trial of Deep Brain Stimulation in Early Patients With Parkinson's Disease
Official Title ICMJE	The Effect of Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinson's Disease and Preserved Psychosocial Competence (EARLYSTIM-study)
Brief Summary	Parkinsons' disease is one of the most disabling chronic neurological diseases. It can be treated sufficiently until motor complications with fluctuations of mobility and dyskinesias develop. The quality of life and the social and occupational functioning is relentlessly deteriorating with longer disease duration once the complications of conservative therapy develop. High-frequency stimulation of the subthalamic nucleus especially improves the motor complications of Parkinson's disease and preliminary data suggest that also the quality of life and psychosocial handicap are improved. So far this therapy is only used for patients which have already undergone personal, professional and social degradation due to motor complications of the disease. The aim of this study is to assess the use of this therapy in earlier stages of the disease, when motor complications have just developed and before patients are significantly affected in their social and occupational functioning.
Detailed Description	Patients are randomized either to medical treatment or subthalamic stimulation. The observation period is 2 years. The primary outcome criterium: PDQ-39.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Parkinson Disease
Intervention ICMJE	Device: Kinetra and Soletra (neurostimulator, Medtronic); Arm I: Implantation of stimulation electrodes in the STN and best medical treatment Arm II: Best medical treatment only
Study Arms	Active Comparator: I Deep brain stimulation Nucleus subthalamicus and best medical treatment Intervention: Device: Kinetra and Soletra (neurostimulator, Medtronic); Active Comparator: II Best medical treatment Intervention: Device: Kinetra and Soletra (neurostimulator, Medtronic)
Publications *	Lhommée E, Wojtecki L, Czernecki V, Witt K, Maier F, Tonder L, Timmermann L, Hälbig TD, Pineau F, Durif F, Witjas T, Pinsker M, Mehdorn M, Sixel-Döring F, Kupsch A, Krüger R, Elben S, Chabardès S, Thobois S, Brefel-Courbon C, Ory-Magne F, Regis JM, Maltête D, Sauvaget A, Rau J, Schnitzler A, Schüpbach M, Schade-Brittinger C, Deuschl G, Houeto JL, Krack P; EARLYSTIM study group. Behavioural outcomes of subthalamic stimulation and medical therapy versus medical therapy alone for Parkinson's disease with early motor complications (EARLYSTIM trial): secondary analysis of an open-label randomised trial. Lancet Neurol. 2018 Mar;17(3):223-231. doi: 10.1016/S1474-4422(18)30035-8.; Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, Hälbig TD, Hesekamp H, Navarro SM, Meier N, Falk D, Mehdorn M, Paschen S, Maarouf M, Barbe MT, Fink GR, Kupsch A, Gruber D, Schneider GH, Seigneuret E, Kistner A, Chaynes P, Ory-Magne F, Brefel Courbon C, Vesper J, Schnitzler A, Wojtecki L, Houeto JL, Bataille B, Maltête D, Damier P, Raoul S, Sixel-Doering F, Hellwig D, Gharabaghi A, Krüger R, Pinsker MO, Amtage F, Régis JM, Witjas T, Thobois S, Mertens P, Kloss M, Hartmann A, Oertel WH, Post B, Speelman H, Agid Y, Schade-Brittinger C, Deuschl G; EARLYSTIM Study Group. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 Feb 14;368(7):610-22. doi: 10.1056/NEJMoa1205158.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Actual Enrollment ICMJE; (submitted: July 16, 2010)	251
Original Enrollment ICMJE; (submitted: July 19, 2006)	246
Estimated Study Completion Date	June 2012
Actual Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Idiopathic Parkinson's Disease; Hoehn and Yahr stage ≤ 2.5 in the best "on"med condition; Disease duration > 4 years; Presence of fluctuations and/or dyskinesias for no more than 3 years; One of the two following forms of impairment:; Impairment in activities of daily living (UPDRS II > 6) due to PD-symptoms despite medical treatment in the "worst" condition or; Impairment of social and occupational functioning (measured with a modified SOFAS) due to PD-symptoms despite medical treatment (51-80%); PDQ-39 completed; Written informed consent; For the patients in France a social security number is required Exclusion Criteria; Major depression with suicidal thoughts (Beck Depression Inventory > 25); Dementia (Mattis Score ≤ 130); Acute psychosis; Need for nursing care; Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy); Drug or alcohol addiction; Surgical contraindications; Fertile women not using adequate contraceptive methods; Women who are pregnant or breast feeding; Illiteracy or insufficient language skills (German or French) to complete the questionnaires; Simultaneous participation in another clinical trial except that other trial does not affect the Earlystim study as approved and documented by the steering committee
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France, Germany
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00354133
Other Study ID Numbers ICMJE	A 121/06
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	German Parkinson Study Group (GPS)
Study Sponsor ICMJE	German Parkinson Study Group (GPS)
Collaborators ICMJE	University of Schleswig-Holstein; Assistance Publique - Hôpitaux de Paris; KKS Netzwerk
Investigators ICMJE	Principal Investigator: Guenther Deuschl, Prof. Department of Neurology, Christian-Albrechts-University Kiel, Schittenhelmstr. 10, D 24105 Kiel Principal Investigator: Yves Agid, Pr. Groupe Hospitalier Pitié- Salpêtrière, Fédération des Maladies du Système Nerveux, 47-83 Boulevard de l´Hôpital, F- 75651 Paris Cedex 13
PRS Account	German Parkinson Study Group (GPS)
Verification Date	August 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP