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

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German Parkinson Study Group (GPS)
• Collaborators: Assistance Publique - Hôpitaux de Paris; KKS Netzwerk; University Hospital Schleswig-Holstein

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