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

Not Applicable

Recruiting

• Conditions: Parkinson Disease

• 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

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