Peripheral electrical stimulation for Parkinson's (NCT04501133)
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
- SUSPENDED
- 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?
- 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 5 years and 10 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- Healthy participants will be scanned with MRI and undergo PES and/or single pulse TMS during several visits, each with different stimulation patterns.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Brain wave recording (EEG) (non-invasive). Confirm the full schedule with the study coordinator.