NCT06090292

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

October 13, 2023

Last Update Submit

October 18, 2023

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Unified Parkinsons Disease Rating Scale (UPDRS)

    Baseline, T30 (immediately after FES) and T60 (30 minutes after FES).

  • Finger tapping task

    Baseline, T30 (immediately after FES) and T60 (30 minutes after FES).

Study Arms (3)

Real TUS + Real FES

EXPERIMENTAL

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.

Device: Real TUSDevice: Real FES

Real TUS +Sham FES

EXPERIMENTAL

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.

Device: Real TUSDevice: Sham FES

Sham TUS +Real FES

EXPERIMENTAL

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.

Device: Real FESDevice: Sham TUS

Interventions

Real TUSDEVICE

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 TUS + Real FESReal TUS +Sham FES
Real FESDEVICE

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.

Real TUS + Real FESSham TUS +Real FES
Sham TUSDEVICE

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 TUS +Real FES
Sham FESDEVICE

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.

Real TUS +Sham FES

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Confirmed diagnosis of Parkinson's disease
  • Stable dopaminergic medication dose for a minimum of 4 weeks (applicable for PD patients only)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Robert Chen

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Kwok

CONTACT

1 416 603 5800julian.kwok@uhn.ca

Naaz Desai

CONTACT

1 416 603 5800naaz.desai@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

June 13, 2023

Primary Completion

December 13, 2024

Study Completion

June 13, 2025

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)