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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT05148468
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed Parkinson´s Disease with Hoehn Yahr scale between 2,5 and 4,0
* Main complaint of balance or freezing of gait
* Score of 2 or more on subitem 3.11 of the MDS UPDRS scale concerning Freezing of Gait severity.
* Capable of informed consent
Exclusion Criteria:
* Frequent lower limb, lower back or hip pain scoring 3 or more on visual analog scale
* Uncontrolled or serious comorbidities such as uncontrolled diabetes mellitus, renal disease, anticoagulation, immunosuppression or other medical conditions that present a contraindication for SCS surgery
* Psychosis, uncontrolled depression (BDI \>14) or anxiety disorder (BAI \>14)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT05148468
Study Brief:
Protocol Section:
NCT05148468