Ultrasound + Electrical Stimulation for Parkinson's Disease
(tbFUS-FES_PD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Transcranial Ultrasound Stimulation (TUS) is an emerging non-invasive brain stimulation(NIBS) technique that can be used on both superficial and deep brain targets with a high spatial resolution as small as a few cubic millimeters. Functional Electrical stimulation is a peripheral stimulation technique researched and clinically used to restore motor function following conditions like stroke and Spinal cord injury. To date, there are no studies that have looked at the neuro modulatory effects of combining TUS and FES on motor symptoms in patients with Parkinson's disease. The current study aims to understand the neuromodulatory effects of combining tbFUS to bilateral primary motor cortex (M1) in Parkinsons's disease patients immediately followed by bilateral upper extremity FES of the hand muscles for improving motor symptoms.
Will I have to stop taking my current medications?
The trial requires that your Parkinson's medication dose has been stable for at least 4 weeks, so you won't need to stop taking it. However, if you are on antipsychotics, antidepressants, marijuana, or other recreational drugs that affect the nervous system, you may not be eligible to participate.
Is the combination of ultrasound and electrical stimulation safe for humans?
How is the treatment of Ultrasound + Electrical Stimulation for Parkinson's Disease different from other treatments?
This treatment is unique because it combines low-intensity focused ultrasound (a non-invasive method using sound waves to stimulate the brain) with functional electrical stimulation (using electrical currents to activate nerves), offering a novel approach to modulate brain activity and potentially improve motor symptoms in Parkinson's disease.12467
What data supports the effectiveness of the treatment Ultrasound + Electrical Stimulation for Parkinson's Disease?
Research suggests that low-intensity focused ultrasound (LIFU) can improve motor symptoms in Parkinson's disease by affecting brain activity and promoting nerve repair. Preclinical studies indicate that focused ultrasound stimulation is safe and may have beneficial effects on motor behavior in Parkinson's disease.12467
Who Is on the Research Team?
Robert Chen
Principal Investigator
University Health Network, Toronto
Are You a Good Fit for This Trial?
This trial is for people aged 18-90 with confirmed Parkinson's disease who have been on a stable dose of dopaminergic medication for at least 4 weeks. It excludes those with metal implants, drug use affecting the nervous system, cardiac devices, pregnancy, severe psychiatric disorders, history of stroke or seizure, dementia, major hand disabilities, genetic mutations causing illness or infection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive combinations of Real TUS and/or Real FES across 3 study visits, each at least 7 days apart, to assess neuromodulatory effects on motor symptoms
Follow-up
Participants are monitored for changes in motor symptoms and safety after treatment using UPDRS and MEP measurements
What Are the Treatments Tested in This Trial?
Interventions
- Real FES
- Real TUS
- Sham FES
- Sham TUS
Real FES is already approved in United States, European Union, Canada for the following indications:
- Restoration of motor function following stroke and spinal cord injury
- Restoration of motor function following stroke and spinal cord injury
- Restoration of motor function following stroke and spinal cord injury
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor