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

RECRUITINGN/ASponsored by Paragit ApS
Actively Recruiting
PhaseN/A
SponsorParagit ApS
Started2023-12-19
Est. completion2024-08-01
Eligibility
Age50 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06490861

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.

Eligibility

Age: 50 Years+Healthy volunteers accepted
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

Conditions2

Parkinson DiseaseParkinson's Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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