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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT06405334
Eligibility Criteria:
Inclusion Criteria:
Aims 1 and 2 Inclusion criteria:
* All Veterans with a clinical diagnosis of Parkinson's disease as made by their treating neurologist in Hoehn and Yahr stage 2-3 with the ability to give informed consent will be considered for possible participation in this study.
* Veterans cannot be past stage 3 as our measures depend on physical independence and fall risk prediction is less useful after stage 3.
* Capacity to consent will be assessed with the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC).
* A score of less than 14.5 will be used as the cut-off to decide whether a Veteran is capable of consenting as the false positive rate is zero below this score with marginal increases in sensitivity above this score (89% sensitivity, 100% specificity).
Aim 3
Inclusion criteria:
* In addition to the inclusion criteria for Aims 1 and 2, Veterans with an implanted STN DBS lead with a Percept device in place.
Exclusion Criteria:
Aims 1 and 2 Exclusion criteria:
* Veterans with dementia of sufficient severity to impair their ability to make healthcare related decisions for themselves will be excluded.
* Veterans with other forms of parkinsonism (PSP, CBGD, etc.) will be excluded.
* Veterans past H\&Y Stage 3 will be excluded.
* Veterans with symptomatic orthostatic hypotension (defined as sustained drop in systolic blood pressure by 20 mmHg or diastolic blood pressure by 10 mmHg within 3 minutes of standing after being supine for five minutes) will also be excluded as this is an entity the investigators are not characterizing and could confound/bias the dataset.
Aim 3:
Exclusion criteria:
* In addition to the exclusion criteria for Aims 1 and 2, Veterans with DBS leads implanted in other locations will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06405334
Study Brief:
Protocol Section:
NCT06405334