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ParkinSense System Freezing of Gait Clinical Trial NCT07542743

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Summary

NIH has registered a clinical trial (NCT07542743) testing the ParkinSense System for freezing of gait in patients with Parkinson's disease. The multi-site study will enroll participants who will complete a single-visit laboratory assessment followed by two weeks of home use. The primary endpoint measures reduction in percent of time spent frozen during mobility tasks. This is an informational registration only and does not create any compliance obligations.

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What changed

NIH has registered a new clinical trial (NCT07542743) on ClinicalTrials.gov. The ParkinSense System, a customizable multimodal cueing device, will be evaluated for its ability to reduce freezing of gait in Parkinson's disease patients. The trial will involve a controlled laboratory session followed by two weeks of unsupervised home use. No regulatory requirements, reporting obligations, or compliance deadlines are created by this registration. The trial's results may inform future regulatory submissions if the device demonstrates clinical benefit.

Archived snapshot

Apr 22, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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A System to Help With Freezing of Gait in Parkinson's Patients

N/A NCT07542743 Kind: NA Apr 21, 2026

Abstract

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.

Conditions: Freezing of Gait Symptoms in Parkinson Disease

Interventions: ParkinSense System

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Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Industry sector
3345 Medical Device Manufacturing
Activity scope
Clinical trial registration Medical device evaluation Parkinson's disease research
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations

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