Kinematic and Neural Dynamics of Postural Instability in Parkinson's Disease
Recruiting · NCT06405334 · Observational (researchers observe without assigning treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis, Minnesota, United States