NCT06405334 Kinematic and Neural Dynamics of Postural Instability in Parkinson's Disease
| NCT ID | NCT06405334 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Parkinson's Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-11-01 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Robert A McGovern
PRINCIPAL INVESTIGATOR
Minneapolis VA Health Care System, Minneapolis, MN
Frequently Asked Questions
Who can join the NCT06405334 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06405334 currently recruiting?
Yes, NCT06405334 is actively recruiting participants. Contact the research team at Robert.McgovernIII@va.gov for enrollment information.
Where is the NCT06405334 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06405334 clinical trial?
NCT06405334 is sponsored by VA Office of Research and Development. The principal investigator is Robert A McGovern at Minneapolis VA Health Care System, Minneapolis, MN. The trial plans to enroll 100 participants.
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