ParkinSense System for Parkinson's Disease

BC
Overseen ByBrian Clark
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?

The goal of this clinical trial is to learn if the ParkinSense system, a customizable, multimodal, and adaptable cueing system, can assist with freezing of gait (FOG) in patients with Parkinson's disease. The main question it aims to answer is: is the percent of time spent frozen reduced when using the system compared to not using the system? Participants will be asked to take part in a single-visit laboratory study where they will wear the system in a controlled environment, followed by a two weeks of home use.

Who Is on the Research Team?

BC

Brian Clark

Principal Investigator

Barron Associates

Are You a Good Fit for This Trial?

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

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+