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

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.
 
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)

Tracking Information
First Submitted Date  ICMJE July 19, 2006
First Posted Date  ICMJE July 20, 2006
Last Update Posted Date June 26, 2018
Study Start Date  ICMJE July 2006
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
PDQ-39 [ Time Frame: 24 months ]
Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment.
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2006)
Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment.
Change History Complete list of historical versions of study NCT00354133 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
  • UPDRS part III [ Time Frame: 24 months ]
    Change in the Unified Parkinson's disease Rating Scale (UPDRS) part III
  • UPDRS II scale [ Time Frame: 24 months ]
    Change in the UPDRS II scale
  • Safety [ Time Frame: 24 months ]
    Frequency, type and severity of therapy related adverse events of medication or DBS, Change in medication (L-DOPA equivalents)
  • UPDRS VI scale [ Time Frame: 24 months ]
    Change in the UPDRS VI scale
  • SCOPA-PS [ Time Frame: 24 months ]
    Change in the SCOPA-PS scale
  • BDI scale [ Time Frame: 24 months ]
    Change in the BDI scale
  • MADRS scale [ Time Frame: 24 months ]
    Change in the MADRS scale
  • BPRS scale [ Time Frame: 24 months ]
    Change in the BPRS scale
  • Mattis Dementia Scale [ Time Frame: 24 months ]
    Change in the Mattis Dementia Scale
  • Ardouin Behaviour Scale [ Time Frame: 24 months ]
    Change in the Ardouin Behaviour Scale
  • Starkstein-Apathy Scale [ Time Frame: 24 months ]
    Change in the Starkstein-Apathy Scale
  • professional Fitness scale [ Time Frame: 24 months ]
    Change in the professional Fitness scale
  • SF-36 scale [ Time Frame: 24 months ]
    Change in the SF-36 scale
  • pain (VAS) scale, [ Time Frame: 24 months ]
    Change in the pain (VAS) scale
  • clinical global impression (CGI-GI) scale [ Time Frame: 24 months ]
    change in the clinical global impression (CGI-GI) scale
  • "best"-state [ Time Frame: 24 months ]
    Change in the number of hours per day in the "best"-state
  • "best" state dyskinesias [ Time Frame: 24 months ]
    Frequency and severity of "best" state dyskinesias
  • Sleeping-hours per day [ Time Frame: 24 months ]
    Sleeping-hours per day
  • Gait [ Time Frame: 24 months ]
    Changes in gait
  • Speech [ Time Frame: 24 months ]
    Changes in speech
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2006)
  • UPDRS part III(medication-off and on-state), hours per day in the "best ON", Frequency and severity of ON-dyskinesia, Sleeping hours, Gait and speech
  • UPDRS II, SCOPA-PS, BDI, MADRS, BPRS, Mattis Dementia Scale, Starkstein-Apathy Scale, professional fitness, SF-36,pain (VAS), clinical global impression (CGI-GI)
  • Frequency, type and severity of therapy related adverse events of medication or DBS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's Disease
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • 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.
  • Drug: Best Medical Treatment
    Patients in this arm get best medical treatment only
Study Arms  ICMJE
  • 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
    Intervention: Device: Kinetra and Soletra (neurostimulator, Medtronic)
  • Active Comparator: BMT treatment
    Patients in this arm get best medical treatment only.
    Intervention: Drug: Best Medical Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 16, 2010)
251
Original Enrollment  ICMJE
 (submitted: July 19, 2006)
246
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00354133
Other Study ID Numbers  ICMJE A 121/06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Responsible Party German Parkinson Study Group (GPS)
Study Sponsor  ICMJE German Parkinson Study Group (GPS)
Collaborators  ICMJE
  • University of Schleswig-Holstein
  • Assistance Publique - Hôpitaux de Paris
  • KKS Netzwerk
Investigators  ICMJE
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
PRS Account German Parkinson Study Group (GPS)
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP