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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
History of Changes

July 19, 2006
January 27, 2012
July 2006
December 2011   (final data collection date for primary outcome measure)
Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment.
Complete list of historical versions of study NCT00354133 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Controlled Trial of Deep Brain Stimulation in Early Patients With Parkinson's Disease
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)

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.

Patients are randomized either to medical treatment or subthalamic stimulation. The observation period is 2 years. The primary outcome criterium: PDQ-39.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson Disease
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: I
    Deep brain stimulation Nucleus subthalamicus and best medical treatment
    Intervention: Device: Kinetra and Soletra (neurostimulator, Medtronic)
  • Active Comparator: II
    Best medical treatment
    Intervention: Device: Kinetra and Soletra (neurostimulator, Medtronic)
Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, Hälbig TD, Hesekamp H, Navarro SM, Meier N, Falk D, Mehdorn M, Paschen S, Maarouf M, Barbe MT, Fink GR, Kupsch A, Gruber D, Schneider GH, Seigneuret E, Kistner A, Chaynes P, Ory-Magne F, Brefel Courbon C, Vesper J, Schnitzler A, Wojtecki L, Houeto JL, Bataille B, Maltête D, Damier P, Raoul S, Sixel-Doering F, Hellwig D, Gharabaghi A, Krüger R, Pinsker MO, Amtage F, Régis JM, Witjas T, Thobois S, Mertens P, Kloss M, Hartmann A, Oertel WH, Post B, Speelman H, Agid Y, Schade-Brittinger C, Deuschl G; EARLYSTIM Study Group. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 Feb 14;368(7):610-22. doi: 10.1056/NEJMoa1205158.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
251
June 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT00354133
A 121/06
Yes
German Parkinson Study Group (GPS)
German Parkinson Study Group (GPS)
  • University of Schleswig-Holstein
  • Assistance Publique - Hôpitaux de Paris
  • KKS Netzwerk
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
German Parkinson Study Group (GPS)
August 2011

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