Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With Parkinson's Disease (PARPIV23)

July 1, 2024 updated by: Paragit ApS

An Open Multi-centre Investigation to Evaluate the Performance of the Paragit Sleeve With build-in sEMG Sensors, Kinetic Sensors, and Smart-textile to Measure and Monitor Motor Symptoms and Treatment-induced Dyskinesia in Patients With Parkinson's Disease

This investigation is undertaken to:

  • Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and
  • To assess the safety and tolerability of the device in patients with PD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Beata Maria Ana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Parkinson disease: Clinically diagnosed
  2. Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49)

  3. Experiencing at least two of following symptoms and/or side effect on a daily basis:

    • Rigidity
    • Tremor
    • Bradykinesia
    • Dyskinesia (treatment side effect)

  4. Provision of informed consent, i.e., the subject must be able to:

    • Read and understand the Patient Information and Consent Form
    • Sign the Patient Information and Consent Form.

Exclusion Criteria:

  1. Known allergy/hypersensitivity to any material in direct contact with the skin (stainless steel, silicone and polyester)
  2. MMSE <24
  3. Other neurological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paragit
Sleeve to quantify symptoms
Device: Paragit
Sleeve to quantify symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tremor
Time Frame: During the clinical assessment, and for the following 24h.
Tremor will be assessed using the device, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
During the clinical assessment, and for the following 24h.
Bradykinesia
Time Frame: During the clinical assessment, and for the following 24h.
Bradykinesia will be assessed using the device, measured inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
During the clinical assessment, and for the following 24h.
Rigidity
Time Frame: During the clinical assessment, and for the following 24h.
The device will assess rigidity, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
During the clinical assessment, and for the following 24h.
Dyskinesia
Time Frame: During the clinical assessment, and for the following 24h.
The device will assess rigidity, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
During the clinical assessment, and for the following 24h.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: During the clinical assessment , and for the following 24h.
Safety of the Paragit Sleeve by assessment of device deficiencies and adverse events, non-serious and serious, rated for causality.
During the clinical assessment , and for the following 24h.
Usability
Time Frame: During the clinical assessment , and for the following 24h.
The usability of the device will be studied using a questionnaire.
During the clinical assessment , and for the following 24h.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paragit ApS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARPIV23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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