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

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Paragit

• Registration Number: NCT06490861
• Lead Sponsor: Paragit ApS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-19
• Study First Submitted: 2024-06-13
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paragit	Paragit	Sleeve to quantify symptoms

Primary Outcome Measures

Name	Time	Method
Dyskinesia	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.
Tremor	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.
Bradykinesia	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.
Rigidity	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 Outcome Measures

Name	Time	Method
Usability	During the clinical assessment , and for the following 24h.	The usability of the device will be studied using a questionnaire.
Safety	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.

Trial Locations

Locations (1)

Hospital Beata María Ana; 🇪🇸 Madrid, Spain