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 @ 9:27 PM
Ignite Modification Date:
2025-12-24 @ 9:27 PM
NCT ID:
NCT04650932
Eligibility Criteria:
Inclusion Criteria:
* Individuals who are 18 years and older
* Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system
* Individuals who have been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months
* Individuals diagnosed with advanced PD who had bilateral dorsal subthalamic nucleus DBS surgery, as standard of care for motor improvement, with distal contacts of the electrodes implanted into the ventral STN
Exclusion Criteria:
* Individuals unable to provide consent and/or lack capacity to consent
* Individuals diagnosed with any cognitive or physical impairments that would limit their ability to participate in the cognitive testing
* Individuals who score below 15 on the Montreal Cognitive Assessment Test-Blind
* Individuals who score above 20 on the Center for Epidemiologic Studies Depression Scale
* Pregnant women (note: pregnant women are not candidates for DBS surgery), and prisoners
* Non-English speaking individuals. Cognitive tasks will only be conducted in English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04650932
Study Brief:
Protocol Section:
NCT04650932