Effects of Peripheral Electrical Stimulation With Focused Ultrasound on Motor Symptoms in Parkinson's Patients

Parkinson Disease Clinical Trial

— tbFUS-FES_PD  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090292
• Other study ID #: 20-5740 #3
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: June 13, 2025

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: Julian Kwok
• Phone: 1 416 603 5800
• Email: julian.kwok[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

There are 3 study visits and for all of them patients will remain in ON dopaminergic medication condition. Each visit will be a minimum of 7 days apart.

Each visit will contain 1 of 3 combinations:

Combination #1: Real TUS +Sham FES; Combination #2: Sham TUS+ Real FES; Combination #3: Real TUS +Real FES

Definition of:

Real TUS: The Real TUS paradigm will consist of 120s train of 20ms ultrasound bursts, repeated every 200ms (Pulse Repetition Frequency (PRF)=5Hz). The Power of Real tbFUS will be set at 20W.

Sham TUS: The Sham TUS paradigm will also 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.

Real FES: Motor point stimulation (MPS) of the right and left hand and forearm (Muscles stimulated may include: Opponens Pollicis Brevis (OPB), Flexor Pollicis Brevis, Abductor Pollicis Brevis (APB), 1st Lumbrical, Flexor digitorum superficialis and the First Dorsal Interosseous (FDI)) muscles will be 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.).

Sham FES: Motor point stimulation (MPS) of both right and left Biceps and Finger flexor muscles will be 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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 13, 2025
• Est. primary completion date: December 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

History of stroke or seizure

• Comorbid dementia

• Scored below 22 on the Montreal Cognitive Assessment (MoCA)

• Has intracranial implant(s) or device(s)

• Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)

• Has a previous surgical intervention to treat the movement disorder such as lesioning or a Deep Brain Stimulation system in place.

• Presence of metal implanted in body that is contraindicated in TMS/MRI/peripheral electrical stimulation

• Pregnancy

• Major depression/psychiatric disorder that in the opinion of the Investigator will affect patient's understanding of study procedures and willingness to abide by all procedures during the course of the study

• Is on antipsychotics, anti-depressants, marijuana, or other recreational drugs that affect the nervous system

• Major musculoskeletal or neuromuscular disease or disorder of the hands, wrists and limbs

• Severe Dyskinesia

• Genetic mutations

• Major systemic illness or infection

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Real TUS
2 channel transducer from Sonic Concepts will be used to deliver 120s train of 20ms ultrasound bursts, repeated every 200ms (Pulse Repetition Frequency (PRF)=5Hz).
• Real FES
Twin Stim Plus EMS stimulator will be used to deliver FES to right and left hand opponens pollicis, first lumbrical and first dorsal interosseous muscles. Parameters of stimulation are 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.
• Sham TUS
2 channel transducer from Sonic Concepts will be used to deliver 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 scalp.
• Sham FES
Twin Stim Plus EMS stimulator will be used to deliver FES to right and left biceps and long finger flexors. Parameters of stimulation are 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.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Averaged 1mV Motor Evoked Potential (MEP) Amplitude recorded from the right and left FDI, APB and ADM	To obtain this measurement from both hemispheres, a Transcranial magnetic stimulator's (TMS) power output (expressed as %Maximum Stimulator Output or %MSO) will be adjusted to an intensity that consistently evokes MEP peak-to-peak amplitudes of ~1mV in the right and left FDI when applied to the left primary motor cortex (LM1) and right motor cortex (RM1) respectively, before any neuromodulatory intervention (Pre-I 1mV).	Baseline, immediately after sonication (T0) , T30 (immediately after FES) and T60 (30 minutes after FES).
Secondary	Unified Parkinsons Disease Rating Scale (UPDRS)	Change of UPDRS score	Baseline, T30 (immediately after FES) and T60 (30 minutes after FES).
Secondary	Finger tapping task	Correlation of the changes in UPDRS scores with the velocity change during finger tapping task as recorded by an accelerometer	Baseline, T30 (immediately after FES) and T60 (30 minutes after FES).