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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT04587193
Eligibility Criteria:
Inclusion Criteria:
Parkinson's Participant
1. age 21 years or older,
2. PD confirmed by a movement disorder specialist using UK Brain Bank Criteria,
3. H\&Y stage II, III, IV, or V.
Caregiver participant
1. Caregiver of PD participant and is willing to complete questionnaire
2. moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment \< 17/30) except in cases where the clinician and the participants Legally Authorized Representative both determine the participant can safely complete the study
Exclusion Criteria:
Parkinson's Participant
1. neurological, musculoskeletal, or other disorders unrelated to PD contributing to impairment of gait, stance, balance or coordination,
2. history of implantable cardiac device or ablative surgery,
3. moderate to severe cognitive impairment / dementia (Montreal Cognitive Assessment \< 17/30),
4. uncontrolled orthostatic hypotension,
5. feeding tube or associated port placement (PEG/J-PEG),
6. body height less than 5'1" or greater than 6'3" and
7. body weight greater than 250 pounds.
Caregiver participant
1\) Unwilling to complete questionnaire
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
95 Years
Study:
NCT04587193
Study Brief:
Protocol Section:
NCT04587193