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Effects of Peripheral Electrical Stimulation With Focused Ultrasound on Motor Symptoms in Parkinson's Patients (tbFUS-FES_PD)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Real TUS
Real FES
Sham TUS
Sham FES
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Real TUS + Real FES

Real TUS +Sham FES

Sham TUS +Real FES

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Unified Parkinsons Disease Rating Scale (UPDRS)
Change of UPDRS score
Finger tapping task
Correlation of the changes in UPDRS scores with the velocity change during finger tapping task as recorded by an accelerometer

Full Information

First Posted
October 13, 2023
Last Updated
October 18, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT06090292
Brief Title
Effects of Peripheral Electrical Stimulation With Focused Ultrasound on Motor Symptoms in Parkinson's Patients
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
December 13, 2024 (Anticipated)
Study Completion Date
June 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The subject will be blind to stimulation condition (sham/active TUS). The assessor for the finger accelerometry will be blind to stimulation condition (sham/active TUS). The UPDRS examination will be video-recorded and blindly assessed by a research team member.
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real TUS + Real FES
Arm Type
Experimental
Arm Description
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.
Arm Title
Real TUS +Sham FES
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham TUS +Real FES
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Real TUS
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Real FES
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham TUS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham FES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Averaged 1mV Motor Evoked Potential (MEP) Amplitude recorded from the right and left FDI, APB and ADM
Description
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).
Time Frame
Baseline, immediately after sonication (T0) , T30 (immediately after FES) and T60 (30 minutes after FES).
Secondary Outcome Measure Information:
Title
Unified Parkinsons Disease Rating Scale (UPDRS)
Description
Change of UPDRS score
Time Frame
Baseline, T30 (immediately after FES) and T60 (30 minutes after FES).
Title
Finger tapping task
Description
Correlation of the changes in UPDRS scores with the velocity change during finger tapping task as recorded by an accelerometer
Time Frame
Baseline, T30 (immediately after FES) and T60 (30 minutes after FES).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julian Kwok
Phone
1 416 603 5800
Ext
2708
Email
julian.kwok@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Naaz Desai
Phone
1 416 603 5800
Ext
135792
Email
naaz.desai@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Chen
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julian Kwok
Phone
1 416 603 580
Ext
2708
Email
julian.kwok@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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