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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by German Parkinson Study Group (GPS).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Schleswig-Holstein
Assistance Publique - Hôpitaux de Paris
KKS Netzwerk
Information provided by (Responsible Party):
German Parkinson Study Group (GPS)
ClinicalTrials.gov Identifier:
NCT00354133
First received: July 19, 2006
Last updated: January 27, 2012
Last verified: August 2011
  Purpose

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 Intervention Phase
Parkinson Disease
Device: Kinetra and Soletra (neurostimulator, Medtronic)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by German Parkinson Study Group (GPS):

Primary Outcome Measures:
  • Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency, type and severity of therapy related adverse events of medication or DBS, Change in medication (L-DOPA equivalents) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 251
Study Start Date: July 2006
Estimated Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Patients are randomized either to medical treatment or subthalamic stimulation. The observation period is 2 years. The primary outcome criterium: PDQ-39.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354133

Locations
France
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
Germany
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
Investigators
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
  More Information

Additional Information:
No publications provided by German Parkinson Study Group (GPS)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: German Parkinson Study Group (GPS)
ClinicalTrials.gov Identifier: NCT00354133     History of Changes
Other Study ID Numbers: A 121/06
Study First Received: July 19, 2006
Last Updated: January 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: German Institute of Medical Documentation and Information
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by German Parkinson Study Group (GPS):
Parkinson Disease
Deep Brain Stimulation
PDQ-39

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

ClinicalTrials.gov processed this record on October 28, 2014