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:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT02480803
Eligibility Criteria:
Inclusion Criteria:
* Idiopathic Parkinson's Disease with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry;
* Despite optimal pharmacological treatment, at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonia or bradykinesia;
* A life expectancy of at least two years.
Exclusion Criteria:
* Age below 18 years
* Previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy);
* Previous CLI (through a PEG-tube or Nasal Jejuna\| tube);
* Hoehn and Yahr stage 5 at the best moment during the day;
* Other severely disabling disease;
* Dementia or signs of severe cognitive impairment
* Psychosis;
* Current depression;
* Contraindications for DBS surgery, such as a physical disorder making surgery hazardous;
* Contraindications for PEG surgery such as interposed organs, ascites and oesophagogastric varices, or for Duodopa;
* Pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception;
* No informed consent;
* Legally incompetent adults;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02480803
Study Brief:
Protocol Section:
NCT02480803