Understanding balance issues in Veterans with Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on Veterans diagnosed with Parkinson's Disease (PD) to investigate the dynamics of postural instability and its underlying neural mechanisms. By utilizing wearable sensors and deep brain stimulation electrodes, the study aims to collect data on balance and gait in real-world settings. The goal is to enhance the understanding of brain pathways related to balance problems, which could lead to the development of new treatments to improve stability and reduce falls in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Minneapolis VA Health Care System, Minneapolis, MN
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Robert A McGovern — Minneapolis VA Health Care System, Minneapolis, MN
• Study coordinator: Robert A McGovern
• Email: Robert.McgovernIII@va.gov
• Phone: (612) 629-7904

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ginger as a Modifier of Ghrelin Levels in Parkinson’s Disease and REM Sleep Behavior Disorder

  This study tests whether ginger capsules can raise ghrelin levels in people with Parkinson’s disease, REM sleep behavior disorder, and healthy controls.

  Recruiting Cambridge University Hospitals NHS Foundation Trust · Cambridge · NCT07882108

• Intraoperative Microelectrode Recordings with MAVEN vs Standard Equipment

  This study tests whether MAVEN can match the recording data collected during DBS surgery for movement disorders using standard equipment.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07868614

• Mental imagery with self-regulation to help daily activities in Parkinson's disease

  This study tests whether a six-week program of mental imagery combined with self-regulation can help people with Parkinson’s perform daily activities better than standard learning or exercise.

  Recruiting The Hong Kong Polytechnic University · Hong Kong · NCT07860294

• Real-world experiences of Inbrija for Parkinson's OFF episodes

  This study looks at how people with Parkinson’s who use Inbrija for OFF episodes feel and function in daily life.

  Recruiting Merz Pharmaceuticals GmbH · Altmünster and 1 other locations · NCT07797790

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

• Test of RO7568282 in early Parkinson's disease

  This study tests whether RO7568282, compared with placebo, is safe and helps people with early Parkinson's disease who are already taking levodopa.

  Recruiting at 4 sites Phase 2 Hoffmann-La Roche · Boca Raton, Florida and 3 other locations · NCT07781644

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.