Status:
RECRUITING
Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With Parkinson's Disease
Lead Sponsor:
Paragit ApS
Conditions:
Parkinson Disease
Eligibility:
All Genders
50+ years
Phase:
NA
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 safe...
Eligibility Criteria
Inclusion
- Parkinson disease: Clinically diagnosed
- Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49)
- Experiencing at least two of following symptoms and/or side effect on a daily basis:
- Rigidity
- Tremor
- Bradykinesia
- Dyskinesia (treatment side effect)
- 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
- Known allergy/hypersensitivity to any material in direct contact with the skin (stainless steel, silicone and polyester)
- MMSE \<24
- Other neurological diseases
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06490861
Start Date
December 19 2023
End Date
December 31 2024
Last Update
July 8 2024
Active Locations (1)
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1
Hospital Beata María Ana
Madrid, Spain