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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 week
  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 have developed methods to use wearable sensors in the ambulatory setting that can accurately detect a variety of activities and have created a number of quantitative metrics that are specific to PI."
  • "Aim 1 sends PD patients home for one week with five wearable sensors and a neck-worn video camera to create a massive video-validated quantitative dataset of a variety of events that are relevant to analyzing PI at home (walking, turning, sit to stand transitions, near falls/stumbles)."
  • "Aim 2 will use kinematic data obtained from the wearable sensors to develop "deep clinical phenotypes" of postural instability using principal component analysis (PCA) and unsupervised clustering machine learning methods."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for Veterans with Parkinson’s disease. It uses wearable sensors to measure balance and deep brain stimulation wires to record brain signals. Researchers hope to learn why balance problems happen so new treatments can be designed to improve balance and reduce falls.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a Veteran with Parkinson’s disease diagnosed by your treating neurologist, a doctor who treats brain and nerve conditions.
  • Your Parkinson’s disease is at stage 2 or 3 on the Hoehn and Yahr scale, which measures how severe the disease is.
  • You can understand the study and agree to take part. The study team will check this with a short test.
  • For Aim 3, you must also have a deep brain stimulation (DBS) wire in the subthalamic nucleus (STN), a specific brain area, connected to a Percept device.

Who can't join

  • You have dementia—problems with memory and thinking—that keeps you from making your own healthcare decisions.
  • You have another condition that causes Parkinson’s-like symptoms, such as progressive supranuclear palsy or cortical basal ganglionic degeneration.
  • Your Parkinson’s disease is past stage 3.
  • You have a lasting drop in blood pressure when standing that causes symptoms. The study defines this as a drop of at least 20 in the top number or 10 in the bottom number within 3 minutes of standing after lying down for 5 minutes.
  • For Aim 3, you have DBS wires placed in brain areas other than the STN.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 (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

Study sites (1)

MN