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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT06295458
Eligibility Criteria:
Inclusion Criteria:
* PD Diagnosis by UK Brain Bank Criteria
* Hoehn \& Yahr stage I-IV in the off-state
* FOG noted in medical history
* FOG confirmed visually by the examiner in the office
* PD that is levodopa-treated and responsive
* Able to manage 12 hours of "OFF" dopaminergic medication state
* Age 50-80 years
* Able to sign a consent document and willing to participate in all aspects of the study
Exclusion Criteria:
* A diagnosis of atypical Parkinsonism, including vascular Parkinsonism
* Prior treatment with medications that cause Parkinsonism
* Stage V PD -unable to walk independently when OFF
* Absence of levodopa response
* Neurological or orthopedic disorders interfering with gait
* Dementia precluding completing the study protocol, including those meeting criteria for dementia with Lewy bodies
* Major depression based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
* Any medical problems that would preclude participation, including individuals with a history of migraines, tinnitus, or seizures, because sensory stimuli can potentially exacerbate these conditions.
* Profound sensory loss as determined by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT06295458
Study Brief:
Protocol Section:
NCT06295458