Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With Parkinson's Disease (PARPIV23)

Paragit ApS

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: Paragit

Study type: Interventional

Funder types: Industry

Identifiers

NCT06490861

PARPIV23

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

Paragit

Experimental group

Description:

Sleeve to quantify symptoms

Treatment:

Device: Paragit