No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for Veterans with Parkinson's Disease to help understand balance issues. Participants will wear sensors to measure their balance and help researchers learn more about how to improve safety and reduce falls.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease by my neurologist.
I am at Hoehn and Yahr stage 2 or 3.
I can give informed consent.
I have a Percept device in place (if I am joining Aim 3).
You may not be able to join if
I have dementia that affects my decision-making.
I have another type of parkinsonism.
I am past Hoehn and Yahr stage 3.
I have orthostatic hypotension.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Balance problems and falls are among the most common complaints in Veterans with Parkinson's Disease (PD), but there are no effective treatments and the ability to measure balance and falls remains quite poor. This study uses wearable sensors to measure balance and uses deep brain stimulation electrodes to measure electric signals from the brain in Veterans with PD. The investigators hope to use t…
Balance problems and falls are among the most common complaints in Veterans with Parkinson's Disease (PD), but there are no effective treatments and the ability to measure balance and falls remains quite poor. This study uses wearable sensors to measure balance and uses deep brain stimulation electrodes to measure electric signals from the brain in Veterans with PD. The investigators hope to use this data to better understand the brain pathways underlying balance problems in PD so that new treatments to improve balance and reduce falls in Veterans with PD can be designed.
Trial Locations
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City
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Status
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 ca…
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 (progressive supranuclear palsy (PSP), cortical basal ganglionic degeneration (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
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