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
Summary For Families
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 María 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.