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

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ClinicalTrials.gov Identifier: NCT00354133
Recruitment Status : Active, not recruiting
First Posted : July 20, 2006
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
University of Schleswig-Holstein
Assistance Publique - Hôpitaux de Paris
KKS Netzwerk
Information provided by (Responsible Party):
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.


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

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.


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
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: DBS treatment
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
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.

Active Comparator: BMT treatment
Patients in this arm get best medical treatment only.
Drug: Best Medical Treatment
Patients in this arm get best medical treatment only




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


Secondary Outcome Measures :
  1. UPDRS part III [ Time Frame: 24 months ]
    Change in the Unified Parkinson's disease Rating Scale (UPDRS) part III

  2. UPDRS II scale [ Time Frame: 24 months ]
    Change in the UPDRS II scale

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

  4. UPDRS VI scale [ Time Frame: 24 months ]
    Change in the UPDRS VI scale

  5. SCOPA-PS [ Time Frame: 24 months ]
    Change in the SCOPA-PS scale

  6. BDI scale [ Time Frame: 24 months ]
    Change in the BDI scale

  7. MADRS scale [ Time Frame: 24 months ]
    Change in the MADRS scale

  8. BPRS scale [ Time Frame: 24 months ]
    Change in the BPRS scale

  9. Mattis Dementia Scale [ Time Frame: 24 months ]
    Change in the Mattis Dementia Scale

  10. Ardouin Behaviour Scale [ Time Frame: 24 months ]
    Change in the Ardouin Behaviour Scale

  11. Starkstein-Apathy Scale [ Time Frame: 24 months ]
    Change in the Starkstein-Apathy Scale

  12. professional Fitness scale [ Time Frame: 24 months ]
    Change in the professional Fitness scale

  13. SF-36 scale [ Time Frame: 24 months ]
    Change in the SF-36 scale

  14. pain (VAS) scale, [ Time Frame: 24 months ]
    Change in the pain (VAS) scale

  15. clinical global impression (CGI-GI) scale [ Time Frame: 24 months ]
    change in the clinical global impression (CGI-GI) scale

  16. "best"-state [ Time Frame: 24 months ]
    Change in the number of hours per day in the "best"-state

  17. "best" state dyskinesias [ Time Frame: 24 months ]
    Frequency and severity of "best" state dyskinesias

  18. Sleeping-hours per day [ Time Frame: 24 months ]
    Sleeping-hours per day

  19. Gait [ Time Frame: 24 months ]
    Changes in gait

  20. Speech [ Time Frame: 24 months ]
    Changes in speech



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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
Paracelsus-Elena-Klinik, Kassel, Klinikstrasse 16
Kassel, Germany, 34128
Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Schittenhelmstr. 10
Kiel, Germany, 24105
Klinik und Poliklinik für Neurologie
Köln, Germany, 50924
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: Marie Vidailhet, Prof. Groupe Hospitalier Pitié- Salpêtrière, Fédération des Maladies du Système Nerveux, 47-83 Boulevard de l´Hôpital, F- 75651 Paris Cedex 13

Additional Information:
Publications of Results:

Responsible Party: German Parkinson Study Group (GPS)
ClinicalTrials.gov Identifier: NCT00354133     History of Changes
Other Study ID Numbers: A 121/06
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: by inidividual contact with the Coordinatin Investigator Prof.Dr. Deuschl

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