Paragit for Parkinson's (NCT06490861)
Measure tremor and involuntary movements
- 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
- Measure tremor and involuntary movements
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Paragit ApS
- Study Type
- INTERVENTIONAL
- Enrollment
- 25 participants
- Conditions
- Parkinson Disease
- Interventions
- Paragit
Summary For Families
Goal: to check how accurately and reliably a wearable sleeve can measure and record Parkinson's movement problems, including involuntary movements caused by treatment, and to see if the sleeve is safe and comfortable to use. Approach: the Paragit Sleeve is a wearable arm sleeve with built-in sensors that read muscle activity from the skin, motion sensors, and smart fabric to collect movement and muscle data during daily life. Eligibility: people aged 50 and older with a clinical diagnosis of Parkinson's who have at least two daily problems such as stiffness, tremor, slowed movement, or treatment-related involuntary movements, and who can read and sign the consent form. People with allergies to the sleeve materials, significant memory or thinking problems (a screening score below 24 on a common test), or other neurological diseases are not eligible.
Locations
- Hospital Beata María Ana, Madrid, Spain
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Paragit. Goal: to check how accurately and reliably a wearable sleeve can measure and record Parkinson's movement problems, including involuntary movements caused by treatment, and to see if the sleeve is safe and comfortable to use. Approach: the Paragit Sleeve is a wearable arm sleeve with built-in sensors that read muscle activity from the skin, motion sensors, and smart fabric to collect movement and muscle data during daily life. Eligibility: people aged 50 and older with a clinical diagnosis of Parkinson's who have at least two daily problems such as stiffness, tremor, slowed movement, or treatment-related involuntary movements, and who can read and sign the consent form. People with allergies to the sleeve materials, significant memory or thinking problems (a screening score below 24 on a common test), or other neurological diseases are not eligible.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 7 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.