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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT04783493
Eligibility Criteria:
Inclusion Criteria:
1. Men and women (not pregnant) aged between 21 and 80 years old;
2. Participants with idiopathic Parkinson's disease in Hoehn Yahr stages between 2 and 4 (moderate disease) during off-medication, whose primary symptom includes change in gait and / or balance (score equal to or greater than 1 in subitem 2.12 of the MSD scale -UPDRS \["gait and balance"\]). The participant must also present freezing (block) of gait (score equal to or greater than 1 in sub-item 2.13 of the MSD-UPDRS scale - "freezing"). Patients should experience the above symptoms even though they are optimized from the medication point of view. The criteria for being optimized will be defined by a neurologist specialized in movement disorders who will evaluate the case. The presence of freezing will be confirmed through a specific scale (FOG score).
3. Mini-examination of mental status greater than or equal to 24 points;
4. Able to give informed consent in accordance with institutional policies;
5. Able to meet all testing and monitoring requirements, as defined by the study protocol;
Exclusion Criteria:
1. Patients with unstabilized psychiatric comorbidities
2. Impossibility to consent to your participation in the study.
3. Patients with uncontrolled infection or other pre-existing uncontrolled medical conditions (eg, decompensated diabetes, high blood pressure, pneumo or symptomatic heart disease).
4. Concomitant treatment with other experimental drugs.
5. Pregnant or breastfeeding women.
6. Presence of chronic pain in the lower limbs.
7. Patients who are unable to walk without assistance (cane, crutch, walker) or help from another person when they are without their medications for Parkinson's disease (off-medication).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
81 Years
Study:
NCT04783493
Study Brief:
Protocol Section:
NCT04783493