Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Drug: Best Medical TreatmentDevice: Kinetra and Soletra (neurostimulator, Medtronic)
- Registration Number
- NCT00354133
- Lead Sponsor
- German Parkinson Study Group (GPS)
- 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 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.
- 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 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.
The main study (Earlystim) was finished in March 2012 and published in February 2013 (Schuepbach WM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. Feb 14 2013;368(7):610-622.) Patients, who were treated with BMT only in the Earlystim Study were privileged to be operated after the 24 months and a follow up phase of 5 years was planned to elucidate whether earlier stimulation has advantages (or drawbacks) compared to later stimulation.
As operated patients fare better in terms of quality of life and other outcomes (see publication), it will be important to know if patients who are operated earlier keep an advantage in all thoses parameters over those who were operated later or if those operated later will catch up after surgery. Also the pattern of adverse events among earlier and later operated patients may differ. These issues can be addressed with the post-study follow-up (PSFU) studies of the patients of the Earlystim trial. The results of these investigations elucidate longterm issues of DBS in PD and may affect the recommendations of surgery for patients.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 251
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMT treatment Best Medical Treatment Patients in this arm get best medical treatment only. DBS treatment Kinetra and Soletra (neurostimulator, Medtronic) Patients in this arm are treated with Deep Brain Stimulation (DBS) of the Nucleus subthalamicus with the device Kinetra and Soletra (neurostimulator, Medtronic) and addtionally get best medical treatment
- Primary Outcome Measures
Name Time Method PDQ-39 24 months Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment.
- Secondary Outcome Measures
Name Time Method pain (VAS) scale, 24 months Change in the pain (VAS) scale
Speech 24 months Changes in speech
Safety 24 months Frequency, type and severity of therapy related adverse events of medication or DBS, Change in medication (L-DOPA equivalents)
UPDRS VI scale 24 months Change in the UPDRS VI scale
SCOPA-PS 24 months Change in the SCOPA-PS scale
Mattis Dementia Scale 24 months Change in the Mattis Dementia Scale
BDI scale 24 months Change in the BDI scale
SF-36 scale 24 months Change in the SF-36 scale
Sleeping-hours per day 24 months Sleeping-hours per day
Gait 24 months Changes in gait
UPDRS part III 24 months Change in the Unified Parkinson's disease Rating Scale (UPDRS) part III
UPDRS II scale 24 months Change in the UPDRS II scale
MADRS scale 24 months Change in the MADRS scale
BPRS scale 24 months Change in the BPRS scale
Ardouin Behaviour Scale 24 months Change in the Ardouin Behaviour Scale
Starkstein-Apathy Scale 24 months Change in the Starkstein-Apathy Scale
professional Fitness scale 24 months Change in the professional Fitness scale
clinical global impression (CGI-GI) scale 24 months change in the clinical global impression (CGI-GI) scale
"best"-state 24 months Change in the number of hours per day in the "best"-state
"best" state dyskinesias 24 months Frequency and severity of "best" state dyskinesias
Trial Locations
- Locations (16)
Michallon Hospital, CHU Grenoble, Service de Neurologie, BP217
🇫🇷Grenoble Cedex, France
Neurologische Universitätsklinik Freiburg, Breisacher Str. 64
🇩🇪Freiburg, Germany
Service de Neurologie C, Hôpital Neurologique et neurochirurgical Pierre Wertheimer , 59 Bd Pinel 69677 BRON Cedex
🇫🇷Lyon, France
Centre d'investigation Clinique, Pavillon Riser, Hôpital Purpan,Place du Dr Baylac TSA 40031
🇫🇷Toulouse, France
Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Schittenhelmstr. 10
🇩🇪Kiel, Germany
Klinik und Poliklinik für Neurologie
🇩🇪Köln, Germany
"Hôpital Nord Laënnec Boulevard Jacques-Monod - Saint-Herblain
🇫🇷Nantes, France
Hôpital La Milétrie, Tour Jean Bernard, 350 Av Jacques Cœur, BP 577
🇫🇷Poitiers, France
Klinik und Poliklinik für Neurologie, Charite
🇩🇪Berlin, Germany
CIC, CHU Pitié-Salpêtrière, 47-83 Bd de l'Hôpital
🇫🇷Paris Cedex 13, France
Neurologische Klinik der Universität, Moorenstr. 5
🇩🇪Duesseldorf, Germany
Universitätsklinikum Tübingen, Klinik für Neurochirurgie, Hoppe-Seyler-Str.3
🇩🇪Tübingen, Germany
Centre hospitalier La Timone, Service de neurologie et pathologie du mouvement,Boulevard Jean Moulin
🇫🇷Marseille, France
Centre Hospitalo-Universitaire de Rouen, Charles Nicolle, bat. DV, 1 rue de Germont
🇫🇷Rouen, France
Paracelsus-Elena-Klinik, Kassel, Klinikstrasse 16
🇩🇪Kassel, Germany
Klinikum der Universität München Neurologische Klinik und Poliklinik - Großhadern, Marchioninistr. 15
🇩🇪München, Germany