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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00354133
Recruitment Status : Unknown
Verified August 2011 by German Parkinson Study Group (GPS).
Recruitment status was:  Active, not recruiting
First Posted : July 20, 2006
Last Update Posted : January 31, 2012
University of Schleswig-Holstein
Assistance Publique - Hôpitaux de Paris
KKS Netzwerk
Information provided by (Responsible Party):
German Parkinson Study Group (GPS)

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Kinetra and Soletra (neurostimulator, Medtronic) Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : July 2006
Actual Primary Completion Date : December 2011
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: I
Deep brain stimulation Nucleus subthalamicus and best medical treatment
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

Active Comparator: II
Best medical treatment
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

Primary Outcome Measures :
  1. Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Frequency, type and severity of therapy related adverse events of medication or DBS, Change in medication (L-DOPA equivalents) [ Time Frame: 24 months ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00354133

Michallon Hospital, CHU Grenoble, Service de Neurologie, BP217
Grenoble Cedex, France, 38043
Service de Neurologie C, Hôpital Neurologique et neurochirurgical Pierre Wertheimer , 59 Bd Pinel 69677 BRON Cedex
Lyon, France, 69677
Centre hospitalier La Timone, Service de neurologie et pathologie du mouvement,Boulevard Jean Moulin
Marseille, France, 13005
"Hôpital Nord Laënnec Boulevard Jacques-Monod - Saint-Herblain
Nantes, France, 44093
CIC, CHU Pitié-Salpêtrière, 47-83 Bd de l'Hôpital
Paris Cedex 13, France, 75651
Hôpital La Milétrie, Tour Jean Bernard, 350 Av Jacques Cœur, BP 577
Poitiers, France, 86021
Centre Hospitalo-Universitaire de Rouen, Charles Nicolle, bat. DV, 1 rue de Germont
Rouen, France, 76031
Centre d'investigation Clinique, Pavillon Riser, Hôpital Purpan,Place du Dr Baylac TSA 40031
Toulouse, France, 31059
Klinik und Poliklinik für Neurologie, Charite
Berlin, Germany
Neurologische Klinik der Universität, Moorenstr. 5
Duesseldorf, Germany, 40225
Neurologische Universitätsklinik Freiburg, Breisacher Str. 64
Freiburg, Germany, 79106
Neurologische Klinik der Universität Heidelberg, Neuenheimerfeld 400
Heidelberg, Germany, 69120
Paracelsus-Elena-Klinik, Kassel, Klinikstrasse 16
Kassel, Germany, 34128
Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Schittenhelmstr. 10
Kiel, Germany, 24105
Klinikum der Universität München Neurologische Klinik und Poliklinik - Großhadern, Marchioninistr. 15
München, Germany, 81377
Universitätsklinikum Tübingen, Klinik für Neurochirurgie, Hoppe-Seyler-Str.3
Tübingen, Germany, 72076
Sponsors and Collaborators
German Parkinson Study Group (GPS)
University of Schleswig-Holstein
Assistance Publique - Hôpitaux de Paris
KKS Netzwerk
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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: German Parkinson Study Group (GPS) Identifier: NCT00354133     History of Changes
Other Study ID Numbers: A 121/06
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: August 2011

Keywords provided by German Parkinson Study Group (GPS):
Parkinson Disease
Deep Brain Stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases