Status:
UNKNOWN
Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's Disease
Lead Sponsor:
German Parkinson Study Group (GPS)
Collaborating Sponsors:
University Hospital Schleswig-Holstein
Assistance Publique - Hôpitaux de Paris
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Earlystim Study: Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 2 years. The primary outcome criterium: PDQ-39. Post study Follow up studie...
Detailed Description
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 qual...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT00354133
Start Date
July 1 2006
End Date
March 1 2022
Last Update
June 26 2018
Active Locations (16)
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1
Michallon Hospital, CHU Grenoble, Service de Neurologie, BP217
Grenoble, France, 38043
2
Service de Neurologie C, Hôpital Neurologique et neurochirurgical Pierre Wertheimer , 59 Bd Pinel 69677 BRON Cedex
Lyon, France, 69677
3
Centre hospitalier La Timone, Service de neurologie et pathologie du mouvement,Boulevard Jean Moulin
Marseille, France, 13005
4
"Hôpital Nord Laënnec Boulevard Jacques-Monod - Saint-Herblain
Nantes, France, 44093