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NCT Number: NCT06490861

Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Beata María Ana

Madrid, Spain

Location status: Recruiting

Location contact

Juan Pablo Romero, PhD

CONTACT

[email protected]

+34

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson disease: Clinically diagnosed
  • Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49)
  • Experiencing at least two of following symptoms and/or side effect on a daily basis:
  • Rigidity
  • Tremor
  • Bradykinesia
  • Dyskinesia (treatment side effect)
  • 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

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

Treatment and study plan

Paragit

Device

Sleeve to quantify symptoms

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. Usability

    Time frame: During the clinical assessment , and for the following 24h.

    The usability of the device will be studied using a questionnaire.

Sponsors and collaborators

Lead sponsor

Paragit ApS

Industry

Registry information

Official study title

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

Acronym: PARPIV23

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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