This trial is active, not recruiting.

Condition parkinson disease
Treatment kinetra and soletra (neurostimulator, medtronic)
Phase phase 4
Sponsor German Parkinson Study Group (GPS)
Collaborator University of Schleswig-Holstein
Start date July 2006
End date December 2011
Trial size 251 participants
Trial identifier NCT00354133, A 121/06


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Deep brain stimulation Nucleus subthalamicus and best medical treatment
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)
Best medical treatment
kinetra and soletra (neurostimulator, medtronic)
Arm I: Implantation of stimulation electrodes in the STN and best medical treatment Arm II: Best medical treatment only

Primary Outcomes

Difference in the PDQ-39 summary index at 24 months compared to the baseline assessment.
time frame: 24 months

Secondary Outcomes

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
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
Frequency, type and severity of therapy related adverse events of medication or DBS, Change in medication (L-DOPA equivalents)
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

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)
Principal investigator Guenther Deuschl, Prof.
Description Patients are randomized either to medical treatment or subthalamic stimulation. The observation period is 2 years. The primary outcome criterium: PDQ-39.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by German Parkinson Study Group (GPS).