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

NCT06490861 | Recruiting

• 1 other identifier: PARPIV23
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• Tremor

  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

  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

  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

  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 Outcomes (2)

• Safety

  During the clinical assessment , and for the following 24h.

• Usability

  During the clinical assessment , and for the following 24h.

Study Arms (1)

Paragit

EXPERIMENTAL

Sleeve to quantify symptoms

Device: Paragit

Interventions

Paragit DEVICE

Sleeve to quantify symptoms

Paragit

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Paragit ApS: lead

Study Sites (1)

Hospital Beata María Ana

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 8, 2024
• Study Start: December 19, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 31, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

ES (1)