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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT04802733
Eligibility Criteria:
Inclusion Criteria:
* Age 50-78 years old (Canada)
* Age 60-78 years old (United States)
* Diagnosis of Parkinson's Disease made between 3 to 20 years ago
* Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
* Able to participate in all study visits and evaluations, including brain MRI and PET scan
* Existence of a study partner who may act as potential surrogate over long term for ongoing consent
Exclusion Criteria:
* Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease
* Prior Deep Brain Stimulation , lesion therapy, or gene therapy for PD
* Prior surgical or radiation therapy to the brain or spinal cord
* Any medical condition resulting in high risk of immunosuppressive drugs, including any active infectious disease
* Inability to temporarily stop anti-platelet agents or other anti-coagulant medications without serious risk
* Previous or currently active malignant disease within the past 5 years, except basal cell carcinoma or in situ uterine cervical carcinoma that have been treated
* Severe obesity (\>350 lbs) or any condition that prevents use of PET/MRI
* Pregnancy or breastfeeding
* Contraindication to surgery or general anesthesia
* In the opinion of the investigator, any other condition regarded as making subject unsuitable for trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
78 Years
Study:
NCT04802733
Study Brief:
Protocol Section:
NCT04802733