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:
NCT07082595
Eligibility Criteria:
Inclusion Criteria:
* Idiopathic Parkinson's disease with gait and postural stability deficits
* ≥18 years of age
* UPDRS III gait scores 1-3
* UPDRS III postural instability scores 1-3
* Prescribed rehabilitation therapy
* Informed consent as documented by signature
* Adjustments in dopaminergic medication and DBS stimulation to improve
Exclusion Criteria:
* Cognitive impairment, Montreal Cognitive Assessment (MoCa) \< 20
* Other neurological or medical condition that caused sustained clinically relevant gait and/or postural stability deficits
* History of a physical or neurological condition that interferes with study procedures
* Social and/or personal circumstances that interfere with the ability to return for assessments
* Patients taking benzodiazepines or Z-drugs that have a significant effect on sleep EEG
* Recent DBS implant (≤ 6 months)
* Inability to perform outcome assessments without walking aid
* Skin disorders/problems/allergies in face/ear area that could worsen with electrode application (e.g. nickel allergy)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07082595
Study Brief:
Protocol Section:
NCT07082595