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 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT05699161
Eligibility Criteria:
Inclusion Criteria:
* Subjects with UK brain bank criteria for idiopathic Parkinson's disease for a period of not less than one year
* Age 18 - 80; male or female
* Stable PD medication for at least 30 days prior to study enrollment
* A MDS-UPDRS total score \> 20 and \< 50
* Ability to understand the study and sign consent forms
* Intent to comply with all postoperative appointments
* Social support to be able to comply with all follow-up visits
Exclusion Criteria:
* Previous neurological disease or previous brain trauma as a confounding factor
* Cardiovascular disease or any condition that prohibits general anesthesia
* Inability to understand and / or cooperate with investigators
* Subjects that have a history of injury, infection, or deformity of at or near the anatomical site for planned product injection which may increase their risk for infection, injury, or complication related to the product (e.g., prior injury to blood vessels, lymphatics, history of orbital injury/fracture).
* Rash or possible skin infection over surgical sites or face.
* Subjects that use any form of tobacco, including e-cigarettes, more than once a week over the past year.
* Current substance abuse (drugs or alcohol) within the 6 months prior to study enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05699161
Study Brief:
Protocol Section:
NCT05699161