ParkinSense System for Parkinson's Disease

BC
CH
Overseen ByConnie Hoover
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Barron Associates, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the ParkinSense system to determine its effectiveness for people with Parkinson's disease who experience freezing of gait, a condition where the feet feel stuck to the ground. The trial will assess whether using the system reduces the time spent frozen compared to not using it. Participants will initially try the system in a lab and then use it at home for two weeks. Candidates may be suitable if they have been diagnosed with Parkinson's disease, experience freezing of gait, and can still walk. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance daily life for those with Parkinson's disease.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but it's best to confirm with the trial organizers.

What prior data suggests that the ParkinSense system is safe for use in patients with Parkinson's disease?

Research has shown that the ParkinSense system could be a helpful new tool for people with Parkinson's disease. However, detailed safety information specifically for the ParkinSense system is not yet available. The trial is in an early phase, so few studies have examined its safety so far. The trial's progression suggests that early tests or prototypes have not revealed major safety concerns.

Since ParkinSense is a wearable device, not a drug or surgery, it is likely to be gentler on the body. Wearable devices generally pose fewer risks than treatments that enter the body, such as medications or surgeries. Participants will use the ParkinSense system both in a controlled setting and at home, allowing for quick resolution of any potential issues. The trial team will closely monitor participants to ensure safety throughout the study.12345

Why are researchers excited about this trial?

Unlike traditional treatments for Parkinson's disease, which often involve medications like Levodopa to manage symptoms, the ParkinSense System is a non-invasive wearable device. Researchers are excited about this approach because it specifically targets freezing of gait (FOG), a common and challenging symptom of Parkinson's, by potentially providing real-time feedback and cues to help patients regain mobility. This system could offer a new way to manage FOG without relying on medications, possibly reducing side effects and improving quality of life for patients.

What evidence suggests that the ParkinSense system is effective for freezing of gait in Parkinson's disease?

Studies have shown that systems like ParkinSense can effectively measure and monitor symptoms of Parkinson's disease, such as difficulty walking. In this trial, participants will experience two different sequences: one group will use the ParkinSense System first, followed by a control period without it, while the other group will start with the control period and then use the ParkinSense System. The PKG (Personal KinetiGraph) device, which is similar, accurately tracks several Parkinson's symptoms, suggesting ParkinSense might work just as well. Testing these systems in real-life settings has demonstrated their effectiveness in patients' daily lives. This technology shows promise for managing Parkinson's symptoms and could help reduce the time patients have difficulty walking. Overall, early signs are positive for using these systems to help manage Parkinson's symptoms.678910

Who Is on the Research Team?

BC

Brian Clark

Principal Investigator

Barron Associates

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Parkinson's disease who have experienced freezing of gait, can walk on their own, and score at least 21 on a cognitive test. Participants must not have other major health issues that would prevent them from joining.

Inclusion Criteria

I am able to walk on my own.
* Montreal Cognitive Assessment (MOCA) MOCA questionnaire score \>=21.
* Prior identified presence of Freezing of Gait
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Laboratory Protocol

Participants perform a series of gait tests with and without the ParkinSense system in a controlled environment

1 day
1 visit (in-person)

Home-based Protocol

Participants use the ParkinSense system at home for one week and refrain from using it for another week, with daily activity tracking and questionnaires

2 weeks

Follow-up

Participants return to drop off the device and complete follow-up interviews and questionnaires

1 day
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • ParkinSense System

Trial Overview

The study tests the ParkinSense system—a wearable device designed to help reduce episodes where walking suddenly stops (freezing of gait) in Parkinson’s patients. Participants use it during one lab visit and then at home for two weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: ParkinSense first, then ControlExperimental Treatment1 Intervention
Group II: Control first, then ParkinSenseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Barron Associates, Inc.

Lead Sponsor

Trials
11
Recruited
520+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

University of Virginia

Collaborator

Trials
802
Recruited
1,342,000+

Citations

Advancing Parkinson's disease detection through multi ... - PMC

The PSO-optimized model achieved 87.81% accuracy (95% CI: 86.54%–89.13%), and the EWOA-optimized model reached 87.90% accuracy (95% CI: 86.58%– ...

Predicting long term clinical outcomes in Parkinson's ...

We proposed a causal framework for our research objectives so we could model the potential impact of a 30% reduction in disease progression ...

Scientific summary - Devices for remote continuous ...

PKG appears to accurately measure several symptoms of PD, including dyskinesia, bradykinesia, tremor and treatment-related outcomes. PKG also appears to ...

Real-world performance evaluation of a telemonitoring ...

This study evaluates for the first time the performance of a remote monitoring device, unobtrusively, at patients familiar environment, with a PD nurse present ...

a systematic review and network meta-analysis

This study is based on 28 RCTs using network meta-analysis to assess the efficacy of different NIBS in the treatment of PD and to help in ...

Summary of the Best Evidence for Safety Management ... - PMC

Purpose. To retrieve, screen, and summarize the best evidence for the safety management of patients with Parkinson's disease (PD) accompanied by ...

Hospitalization and Parkinson's Disease: Safety, Quality ...

The primary outcomes were receipt of a contraindicated medication, length of stay (LOS) and readmission within 30 days. These outcomes were compared between the ...

Hospitalization and Parkinson's disease: safety, quality and ...

For people with Parkinson's (PWP), hospital admissions can be perilous. Nearly 300,000 PWP are admitted to the hospital each year in the US.

Making Hospitals Safer for People with Parkinson's Disease

These protocols will help hospitals put in place the recommended best practices to make care safer for people with. PD and in doing so, aim to improve health ...

Hospitalization Safety in Parkinson's Disease (PD)

Results: We tracked outcomes encompassing 653 encounters. We present baseline data for the following safety outcomes: falls (0.6%), contraindicated ...