Recruiting

Peripheral Electrical Stimulation

Sponsor:

University Health Network, Toronto

Code:

NCT06090292

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Real TUS

Real FES

Sham TUS

Sham FES

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT06090292

Start date

Jun 13, 2023

Status verified date

Oct, 2023

Completion date

Jun 13, 2025

Anticipated

Primary completion date

Dec 13, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Averaged 1mV Motor Evoked Potential (MEP) Amplitude recorded from the right and left FDI, APB and ADM [ Time Frame: Baseline, immediately after sonication (T0) , T30 (immediately after FES) and T60 (30 minutes after FES). ]

Central Contacts and Locations

Central contacts

Julian Kwok

1 416 603 5800julian.kwok@uhn.ca

Naaz Desai

1 416 603 5800naaz.desai@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Julian Kwok

1 416 603 580julian.kwok@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 19, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2023-10-19.