Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's Disease (EARLYSTIM)
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Deep Brain Stimulation, PDQ-39
Eligibility Criteria
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
Sites / Locations
- Michallon Hospital, CHU Grenoble, Service de Neurologie, BP217
- Service de Neurologie C, Hôpital Neurologique et neurochirurgical Pierre Wertheimer , 59 Bd Pinel 69677 BRON Cedex
- Centre hospitalier La Timone, Service de neurologie et pathologie du mouvement,Boulevard Jean Moulin
- "Hôpital Nord Laënnec Boulevard Jacques-Monod - Saint-Herblain
- CIC, CHU Pitié-Salpêtrière, 47-83 Bd de l'Hôpital
- Hôpital La Milétrie, Tour Jean Bernard, 350 Av Jacques Cœur, BP 577
- Centre Hospitalo-Universitaire de Rouen, Charles Nicolle, bat. DV, 1 rue de Germont
- Centre d'investigation Clinique, Pavillon Riser, Hôpital Purpan,Place du Dr Baylac TSA 40031
- Klinik und Poliklinik für Neurologie, Charite
- Neurologische Klinik der Universität, Moorenstr. 5
- Neurologische Universitätsklinik Freiburg, Breisacher Str. 64
- Paracelsus-Elena-Klinik, Kassel, Klinikstrasse 16
- Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Schittenhelmstr. 10
- Klinik und Poliklinik für Neurologie
- Klinikum der Universität München Neurologische Klinik und Poliklinik - Großhadern, Marchioninistr. 15
- Universitätsklinikum Tübingen, Klinik für Neurochirurgie, Hoppe-Seyler-Str.3
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
DBS treatment
BMT treatment
Patients in this arm are treated with Deep Brain Stimulation (DBS) of the Nucleus subthalamicus with the device Kinetra and Soletra (neurostimulator, Medtronic) and addtionally get best medical treatment
Patients in this arm get best medical treatment only.