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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT06868160
Eligibility Criteria:
Inclusion Criteria:
* 45 years \< age ≤ 85 years
* Idiopathic PD according to the Movement Disorders Society (MDS) diagnostic criteria
* Hoehn \& Yahr (H\&Y) score ≤ 4
* PIGD phenotype
* Stable dopaminergic medication for at least 4 weeks and without any changes during the observation period (28 weeks)
* No dementia according to Litvan\'s criteria and Mini-Mental Status Examination score (MMSE) ≥ 24
* No significant tremor/involuntary movements that could determine artifacts during the MRI acquisition
* Oral and written informed consent to study participation
Healthy controls' inclusion criteria:
* Sex-matched and age-matched (age range: mean age of PD years ± 15 years)
* Oral and written informed consent to study participation
Exclusion Criteria:
* Any major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability
* Medical conditions or substance abuse that could interfere with cognition
* Pacemaker or other implanted neurostimulation devices in the head/neck district
* (Other) Contraindications to undergoing MRI examination
* Brain damage at routine MRI, including extensive cerebrovascular disorders
* Denied oral and written informed consent to study participation
* Significant scalp traumatic or surgical wounds or scalp alterations that could determine a risk of infection in the site of non-invasive stimulation or the spread of excessive current from the device (only for patients receiving the neurostimulation).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT06868160
Study Brief:
Protocol Section:
NCT06868160