NCT06405334Recruiting
Kinematic and Neural Dynamics of Postural Instability in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 3 May 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Parkinson disease
- NCT number
- NCT06405334
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Nov 2024 to the primary completion date, 31 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Veterans with dementia of sufficient severity to impair their ability to make healthcare related decisions for themselves will be excluded
Other
- Aims 1 and 2 Exclusion criteria:
- 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:
- In addition to the exclusion criteria for Aims 1 and 2, Veterans with DBS leads implanted in other locations will be excluded
Who the study is looking for
- 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
- In addition to the inclusion criteria for Aims 1 and 2, Veterans with an implanted STN DBS lead with a Percept device in place
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.