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Kinematic and Neural Dynamics of Postural Instability in Parkinson's Disease

RECRUITINGSponsored by VA Office of Research and Development
Actively Recruiting
SponsorVA Office of Research and Development
Started2024-11-01
Est. completion2028-10-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions1

Parkinson's Disease

Locations1 site

Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Robert A McGovern(612) 629-7904Robert.McgovernIII@va.gov

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