Monitor involuntary movements and tremor

Trial ID
NCT06490861
Official Title
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
Goal
Monitor involuntary movements and tremor
Phase
NA
Status
RECRUITING
Sponsor
Paragit ApS
Study Type
INTERVENTIONAL
Enrollment
25 participants
Conditions
Parkinson Disease
Interventions
Paragit

Plain-Language Summary

The goal is to see whether a wearable smart sleeve can accurately measure and monitor Parkinson's motor symptoms and levodopa-induced dyskinesia, giving clinicians objective data to guide treatment. The Paragit sleeve is a smart-textile you wear on an arm or leg with built-in surface EMG sensors and kinetic motion sensors that record muscle electrical activity and movement patterns to detect rigidity, tremor, bradykinesia, and involuntary dyskinesia, it is a noninvasive monitor that does not change medications but collects data alongside your usual levodopa. The trial seeks adults 50 and older with a clinical Parkinson's diagnosis who experience at least two of those symptoms daily and can give informed consent; people with skin allergies to stainless steel, silicone, or polyester, an MMSE under 24, or other neurological diseases are excluded.

Locations

  • Hospital Beata MarĂ­a Ana, Madrid, Spain

Frequently Asked Questions

What is this trial testing?
This trial is studying Paragit. The goal is to see whether a wearable smart sleeve can accurately measure and monitor Parkinson's motor symptoms and levodopa-induced dyskinesia, giving clinicians objective data to guide treatment. The Paragit sleeve is a smart-textile you wear on an arm or leg with built-in surface EMG sensors and kinetic motion sensors that record muscle electrical activity and movement patterns to detect rigidity, tremor, bradykinesia, and involuntary dyskinesia, it is a noninvasive monitor that does not change medications but collects data alongside your usual levodopa. The trial seeks adults 50 and older with a clinical Parkinson's diagnosis who experience at least two of those symptoms daily and can give informed consent; people with skin allergies to stainless steel, silicone, or polyester, an MMSE under 24, or other neurological diseases are excluded.
Who can participate?
Participants must be at least 50 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 7 months.

View on ClinicalTrials.gov