Controlled Trial of Deep Brain Stimulation in Early Patients With Parkinson's Disease
This study is ongoing, but not recruiting participants.
Sponsor:
German Parkinson Study Group (GPS)
Collaborators:
University of Schleswig-Holstein
Assistance Publique - Hôpitaux de Paris
Koordinierungszentrum für Klinische Studien Marburg (KKS), Germany
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
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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
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
Koordinierungszentrum für Klinische Studien Marburg (KKS), Germany
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 Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 19, 2013