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

Paragit ApS25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

ParagitDEVICE

Sleeve to quantify symptoms

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Beata María Ana

Madrid, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

Safety

Safety of the Paragit Sleeve by assessment of device deficiencies and adverse events, non-serious and serious, rated for causality.

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

Usability

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

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

Data from ClinicalTrials.gov

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