NCT07542743

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 9, 2026

Last Update Submit

April 20, 2026

Conditions

Freezing of Gait Symptoms in Parkinson Disease

Keywords

FOGFreezing of GaitParkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Percent of time frozen

    The total duration of annotated FOG events for that sequence divided by the total duration of the sequence.

    Day 1 (during the laboratory visit)

Secondary Outcomes (8)

  • Gait speed

    Day 1

  • Step Cadence

    Day 1

  • Step cadence variability

    Day 1

  • Average step length

    Day 1

  • Activity level

    Week 1 and week 2

  • +3 more secondary outcomes

Study Arms (2)

ParkinSense first, then Control

EXPERIMENTAL

Participants will perform the FOG-inducing protocol first wearing the ParkinSense instrument, and then again without wearing it. During the home study, participants will first wear the ParkinSense instrument for one week, and then not wear the ParkinSense instrument for one week.

Device: ParkinSense System

Control first, then ParkinSense

EXPERIMENTAL

Participants will perform the FOG-inducing protocol first without wearing the ParkinSense instrument, and then while wearing the system. During the home study, participants will first not wear the ParkinSense instrument for one week, and then wear the ParkinSense instrument for the second week.

Device: ParkinSense System

Interventions

ParkinSense SystemDEVICE

The noninvasive, body-worn ParkinSense system is intended help patients with Parkinson's prevent freezing of gait (FOG) and resume ambulation when FOG occurs. The system provides multiple modes of cueing, offers extensive cue personalization, and automatically detects FOG and issues one or more cues that have been tailored to an individual when FOG is detected.

Control first, then ParkinSenseParkinSense first, then Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of idiopathic Parkinson's Disease
  • Prior identified presence of Freezing of Gait
  • Ability to ambulate;
  • Montreal Cognitive Assessment (MOCA) MOCA questionnaire score \>=21.

You may not qualify if:

  • Peripheral neuropathy
  • Dementia
  • Severe gait abnormalities not related to Parkinson's Disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Brian Clark

    Barron Associates

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Clark

CONTACT

434-973-1215clark1n@bainet.com

Connie Hoover

CONTACT

434-973-1215

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 21, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

US(1)