15 Participants Needed

Ultrasound + Electrical Stimulation for Parkinson's Disease

(tbFUS-FES_PD Trial)

JK
ND
Overseen ByNaaz Desai
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
Must be taking: Dopaminergic medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Studies have shown that low-intensity focused ultrasound (LIFU) can safely modulate human brain activity, offering non-invasive and reversible effects. This technology has been used in research for Parkinson's disease and other conditions, demonstrating safety in humans.12345

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?

RC

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

I have been diagnosed with Parkinson's disease.
My Parkinson's medication dose has been stable for at least 4 weeks.

Exclusion Criteria

Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
You have metal inside your body that could cause problems during certain medical tests or procedures.
I am currently using medications or substances that impact my nervous system.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

3 weeks
3 visits (in-person)

Follow-up

Participants are monitored for changes in motor symptoms and safety after treatment using UPDRS and MEP measurements

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Real FES
  • Real TUS
  • Sham FES
  • Sham TUS
Trial Overview The study tests combining Transcranial Ultrasound Stimulation (TUS) targeting the brain and Functional Electrical Stimulation (FES) on hand muscles to improve motor symptoms in Parkinson's patients. Participants will receive either real TUS and FES or sham (fake) versions to compare effects.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Sham TUS +Real FESExperimental Treatment2 Interventions
The Sham tbFUS paradigm will consist of 120s train of 20ms ultrasound bursts, repeated every 200ms (Pulse Repetition Frequency (PRF)=5Hz), however the ultrasound head will be flipped so that the active side faces away from the head. This will be followed by motor point stimulation (MPS) of the right and left hand and forearm muscles i.e. Opponens Pollicis Brevis (OPB), 1st Lumbrical and First Dorsal Interosseous (FDI) muscles triggered in congruence with the voluntary effort of the participant during execution of bilateral functional tasks involving the use of two and three finger pinch grip (e.g.: picking up and moving marbles, ball bearings etc.). Parameters of stimulation will be 40 Hz frequency, 300 microsecs pulse duration, amplitude as per participant tolerance and total stimulation time 30 mins with "ON" time of 4 secs and "OFF" time of 4 secs.
Group II: Real TUS +Sham FESExperimental Treatment2 Interventions
Participants will receive Real TUS using a 2 channel transducer with parameters' of sonication being 120s train of 20ms ultrasound bursts, repeated every 200ms (Pulse Repetition Frequency (PRF)=5Hz). The Power of Real tbFUS will be set at 20W. This will be followed by motor point stimulation (MPS) of the right and left biceps and long finger flexors triggered in congruence with the voluntary effort of the participant during execution of bilateral functional tasks involving the use of two and three finger pinch grip (e.g.: picking up and moving marbles, ball bearings etc.). Parameters of stimulation will be 40 Hz frequency, 300 microsecs pulse duration, amplitude as per participant tolerance and total stimulation time 30 mins with "ON" time of 4 secs and "OFF" time of 4 secs.
Group III: Real TUS + Real FESExperimental Treatment2 Interventions
Participants will receive Real TUS using a 2 channel transducer with parameters' of sonication being 120s train of 20ms ultrasound bursts, repeated every 200ms (Pulse Repetition Frequency (PRF)=5Hz). The Power of Real tbFUS will be set at 20W. This will be followed by motor point stimulation (MPS) of the right and left hand and forearm muscles i.e. Opponens Pollicis Brevis (OPB), 1st Lumbrical and First Dorsal Interosseous (FDI) muscles triggered in congruence with the voluntary effort of the participant during execution of bilateral functional tasks involving the use of two and three finger pinch grip (e.g.: picking up and moving marbles, ball bearings etc.). Parameters of stimulation will be 40 Hz frequency, 300 microsecs pulse duration, amplitude as per participant tolerance and total stimulation time 30 mins with "ON" time of 4 secs and "OFF" time of 4 secs.

Real FES is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Functional Electrical Stimulation for:
  • Restoration of motor function following stroke and spinal cord injury
🇪🇺
Approved in European Union as Functional Electrical Stimulation for:
  • Restoration of motor function following stroke and spinal cord injury
🇨🇦
Approved in Canada as Functional Electrical Stimulation for:
  • 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

Trials
1,555
Recruited
526,000+

Published Research Related to This Trial

Low-intensity transcranial focused ultrasound (TUS) significantly increased motor cortex excitability in Parkinson's disease patients, as evidenced by higher TMS-elicited motor-evoked potentials (MEPs) after active stimulation compared to sham treatment.
Despite the increase in motor cortex excitability, there were no significant changes in clinical outcomes measured by the MDS-UPDRS-III scale, indicating that while a-tbTUS is a feasible neuromodulation strategy, its effects on clinical symptoms may require further investigation.
Accelerated Transcranial Ultrasound Neuromodulation in Parkinson's Disease: A Pilot Study.Samuel, N., Ding, MYR., Sarica, C., et al.[2023]
Non-invasive focused ultrasound stimulation (FUS) has been shown to be safe and beneficial in modulating motor behavior in preclinical studies of Parkinson's disease, suggesting its potential as a novel treatment option.
The review included 11 studies, primarily from China, indicating that while FUS shows promise in influencing Parkinson's disease processes, more research is needed to fully understand its mechanisms before it can be widely implemented in clinical practice.
Focused Ultrasound Stimulation as a Neuromodulatory Tool for Parkinson's Disease: A Scoping Review.Lee, KS., Clennell, B., Steward, TGJ., et al.[2022]
Low-intensity focused ultrasound (LIFU) has shown promise in improving motor symptoms of Parkinson's disease by regulating microglia activation and promoting nerve repair, making it a potential non-invasive treatment option.
Combining LIFU with microbubbles can enhance drug delivery across the blood-brain barrier, highlighting the need for effective drug carrier systems in future Parkinson's disease therapies.
Low intensity focused ultrasound: a new prospect for the treatment of Parkinson's disease.Zhong, YX., Liao, JC., Liu, X., et al.[2023]

Citations

Accelerated Transcranial Ultrasound Neuromodulation in Parkinson's Disease: A Pilot Study. [2023]
Focused Ultrasound Stimulation as a Neuromodulatory Tool for Parkinson's Disease: A Scoping Review. [2022]
Low intensity focused ultrasound: a new prospect for the treatment of Parkinson's disease. [2023]
The emerging role of transcranial magnetic resonance imaging-guided focused ultrasound in functional neurosurgery. [2022]
Clinical application of magnetic resonance-guided focused ultrasound in Parkinson's disease: a meta-analysis of randomized clinical trials. [2022]
Low Intensity Focused Ultrasound for Non-invasive and Reversible Deep Brain Neuromodulation-A Paradigm Shift in Psychiatric Research. [2022]
Feasibility and Safety of MR-Guided Focused Ultrasound Lesioning in the Setting of Deep Brain Stimulation. [2019]
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