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

NCT ID: NCT06490861

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-19

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Paragit

Sleeve to quantify symptoms

Group Type EXPERIMENTAL

Paragit

Intervention Type DEVICE

Sleeve to quantify symptoms

Interventions

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Paragit

Sleeve to quantify symptoms

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paragit ApS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Beata María Ana

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Juan Pablo Romero, PhD

Role: primary

Other Identifiers

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PARPIV23

Identifier Type: -

Identifier Source: org_study_id

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