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 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT04683861
Eligibility Criteria:
Inclusion Criteria:
1. aged between 40 and 76 years
2. patients with advanced Parkinson's disease, or multiple system atrophy with predominant parkinsonism or progressive supranuclear palsy (PSP)
3. with significant freezing of gait ( Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale III item 11≥2), and the gait dysfunction treatable by medication but not adequately controlled with medications.
4. Understand potential risk/benefit, consent to the study, study procedures, and agree to complete the study follow-up visits and comply with the study protocol requirements.
Exclusion Criteria:
1. cognitive impairment ( MMSE≤24), depression (HAMD\>24),acute psychosis, active alcohol or drug abuse, terminal illness, and any major medical or psychological histories, diagnoses, conditions, or comorbidities that would interfere with participation in the study per the investigatior's medical judgment
2. surgical or medical contraindications to spinal cord stimulation surgery(e.g. uncontrolled hypertension, advanced coronary artery disease).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
76 Years
Study:
NCT04683861
Study Brief:
Protocol Section:
NCT04683861