Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT00354133
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00354133
Study Brief:
Protocol Section:
NCT00354133