Measuring motor symptoms in Parkinson's Disease with the Paragit Sleeve
An Open Multi-centre Investigation to Evaluate the Performance of the Paragit Sleeve With build-in sEMG Sensors, Kinetic Sensors, and Smart-textile to Measure and Monitor Motor Symptoms and Treatment-induced Dyskinesia in Patients With Parkinson's Disease
NA · Paragit ApS · NCT06490861
This study tests if the Paragit Sleeve can accurately track motor symptoms in people with Parkinson's Disease and checks if it's safe and comfortable for them to use.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Paragit ApS (industry) |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06490861 on ClinicalTrials.gov |
What this trial studies
This investigation evaluates the accuracy and reliability of the Paragit Sleeve device in measuring and recording motor symptoms associated with Parkinson's Disease. The study aims to assess both the safety and tolerability of the device in patients diagnosed with Parkinson's. Participants will wear the device to monitor symptoms such as rigidity, tremor, bradykinesia, and dyskinesia. The study focuses on individuals aged 50 and older who experience these symptoms daily.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 and older with a clinical diagnosis of Parkinson's Disease who experience at least two motor symptoms daily.
Not a fit: Patients with known allergies to materials in contact with the skin or those with other neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a reliable method for monitoring motor symptoms in Parkinson's patients, leading to better management of their condition.
How similar studies have performed: While there may be other studies focusing on monitoring Parkinson's symptoms, the specific use of the Paragit Sleeve represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Madrid
- Hospital Beata María Ana — Madrid, Spain (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease