Reduce upper limb tremor severity
- Trial ID
- NCT04501133
- Official Title
- Sensory-specific Peripheral Stimulation for Tremor Management
- Goal
- Reduce upper limb tremor severity
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Shirley Ryan AbilityLab
- Study Type
- INTERVENTIONAL
- Enrollment
- 180 participants
- Conditions
- Parkinson's Disease, Essential Tremor
- Interventions
- Peripheral electrical stimulation, Single pulse TMS
Summary For Families
The goal is to reduce troublesome arm tremor in Parkinson's disease and essential tremor by changing the sensory input that helps drive the shaking. The approach uses brief electrical pulses to sensory nerves in the affected limb, aiming to reset sensorimotor circuits and dampen tremor, while single-pulse transcranial magnetic stimulation is used noninvasively to measure how the brain's motor pathways respond. The trial enrolls adults 18 to 80, including people with physician-diagnosed PD or ET who have moderate to severe upper-limb tremor, plus healthy volunteers for comparison; key exclusions include implanted metal or pacemakers, a history of seizures, pregnancy, severe psychiatric or neurological disease, or inability to withhold tremor medications on the day of testing. About 180 people are expected to take part.
Locations
- Shirley Ryan AbilityLab, Chicago, Illinois, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Peripheral electrical stimulation. The goal is to reduce troublesome arm tremor in Parkinson's disease and essential tremor by changing the sensory input that helps drive the shaking. The approach uses brief electrical pulses to sensory nerves in the affected limb, aiming to reset sensorimotor circuits and dampen tremor, while single-pulse transcranial magnetic stimulation is used noninvasively to measure how the brain's motor pathways respond. The trial enrolls adults 18 to 80, including people with physician-diagnosed PD or ET who have moderate to severe upper-limb tremor, plus healthy volunteers for comparison; key exclusions include implanted metal or pacemakers, a history of seizures, pregnancy, severe psychiatric or neurological disease, or inability to withhold tremor medications on the day of testing. About 180 people are expected to take part.
- Who can participate?
- Participants must be between 18 Years and 80 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 5 years and 3 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.