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

NCT00354133 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2018-06-26

No results posted yet for this study

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 studies: After the 24 months observation period also BMT patients could be operated and all patients will be observed for 10 years or longer to elucidate whether earlier stimulation has advantages (or drawbacks) compared to later stimulation.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Kinetra and Soletra (neurostimulator, Medtronic)

Patients in this arm were implanted with a neurostimulator (Kinetra and Soletra from Medtronic) are stimulated. Additionally the get best medical treatment.

DRUG

Best Medical Treatment

Patients in this arm get best medical treatment only

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • KKS Netzwerk

    collaborator NETWORK

  • German Parkinson Study Group (GPS)

    lead OTHER

Principal Investigators

  • Guenther Deuschl, Prof. · Department of Neurology, Christian-Albrechts-University Kiel, Schittenhelmstr. 10, D 24105 Kiel

  • Marie Vidailhet, Prof. · Groupe Hospitalier Pitié- Salpêtrière, Fédération des Maladies du Système Nerveux, 47-83 Boulevard de l´Hôpital, F- 75651 Paris Cedex 13

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00354133 on ClinicalTrials.gov