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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT07092995
Eligibility Criteria:
Inclusion Criteria:
* Patients meeting the MDS clinical diagnostic criteria for Parkinson's disease who are implanted with a Medtronic Percept DBS Device and SenSight Directional Leads in bilateral globus pallidus internus (GPi).
* Able to walk unassisted indoors
* Age 18 or older
* Half of patients will have disabling freezing of gait as defined by freezing more than once per day by self-report on questions 1 \& 2 of the New Freezing of Gait Questionnaire
* The other half of patients will not have freezing of gait as defined by self-report on question 1 of the New Freezing of Gait Questionnaire
Exclusion Criteria:
* Clinical diagnosis of dementia or severe cognitive impairment (MOCA \< 21)
* History of stroke, traumatic brain injury, or other neurologic disorders besides Parkinson's disease
* Comorbidities causing severe gait impairments
* Unstable medical condition including cardio-vascular instability in the past 6 months
* Unable or unwilling to comply with the testing protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07092995
Study Brief:
Protocol Section:
NCT07092995