Investigating the Effects of Peripheral Electrical Stimulation in Combination With Low Intensity Focused Ultrasound for Upper Extremity Motor Symptoms in Patients With Parkinson Disease (PD)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 18-90 years of age

• Confirmed diagnosis of Parkinson's disease

• Stable dopaminergic medication dose for a minimum of 4 weeks (applicable for PD patients only)

Locations
Other Locations
Canada
Toronto Western Hospital
RECRUITING
Toronto
Contact Information
Primary
Julian Kwok
julian.kwok@uhn.ca
1 416 603 5800
Backup
Naaz Desai
naaz.desai@uhn.ca
1 416 603 5800
Time Frame
Start Date: 2023-06-13
Estimated Completion Date: 2025-06-13
Participants
Target number of participants: 15
Treatments
Experimental: Real TUS + Real FES
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.
Experimental: Real TUS +Sham FES
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.
Experimental: Sham TUS +Real FES
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.
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov