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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05871151
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of PD by a board-certified neurologist
* age between 35 and 80 years
* no walking aids
* stable medication 4 weeks prior to and during the study
* no falls in the past 6 months
* participant must have MD who is willing to provide oversight and approval for clinically defined OFF state
Exclusion Criteria:
* mild cognitive impairment (MoCA \<25)
* self reported depression
* antidepressive or antipsychotic medication
* participation in a VNS study in the past year
* disabling bradykinesia to ensure patients are able to participate in intensive physiotherapy (based on clinical impression and in accordance to UPDRS part III item 14 - to be administered in clinic)
* prior history of cardiovascular, neurological or musculoskeletal disorders known to interfere with testing PD features
* implanted medical device of any type
* history of seizures
* peripheral neuropathy including temporal mandibular disorders and Bells Palsy, and
* vasovagal syncope.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT05871151
Study Brief:
Protocol Section:
NCT05871151