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Ultrasound + Electrical Stimulation for Parkinson's Disease (tbFUS-FES_PD Trial)

N/A

Recruiting

Led By Robert Chen

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-90 years of age

Confirmed diagnosis of Parkinson's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, t30 (immediately after fes) and t60 (30 minutes after fes).

Awards & highlights

tbFUS-FES_PD Trial Summary

This trial seeks to understand how combining ultrasound & electrical stimulation to the brain and extremities could improve motor symptoms in Parkinson's patients.

Who is the study for?

This trial is for people aged 18-90 with confirmed Parkinson's disease who have been on a stable dose of dopaminergic medication for at least 4 weeks. It excludes those with metal implants, drug use affecting the nervous system, cardiac devices, pregnancy, severe psychiatric disorders, history of stroke or seizure, dementia, major hand disabilities, genetic mutations causing illness or infection.Check my eligibility

What is being tested?

The study tests combining Transcranial Ultrasound Stimulation (TUS) targeting the brain and Functional Electrical Stimulation (FES) on hand muscles to improve motor symptoms in Parkinson's patients. Participants will receive either real TUS and FES or sham (fake) versions to compare effects.See study design

What are the potential side effects?

Potential side effects may include discomfort from electrical stimulation on skin and possible headache or dizziness from ultrasound stimulation. Since this is an exploratory study, other unexpected side effects might occur.

tbFUS-FES_PD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 90 years old.

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I have been diagnosed with Parkinson's disease.

tbFUS-FES_PD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, t30 (immediately after fes) and t60 (30 minutes after fes).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, t30 (immediately after fes) and t60 (30 minutes after fes).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, t30 (immediately after fes) and t60 (30 minutes after fes). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Averaged 1mV Motor Evoked Potential (MEP) Amplitude recorded from the right and left FDI, APB and ADM

Secondary outcome measures

Finger tapping task

Unified Parkinsons Disease Rating Scale (UPDRS)

tbFUS-FES_PD Trial Design

3Treatment groups

Experimental Treatment

Group I: Sham TUS +Real FESExperimental Treatment2 Interventions

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.

Group II: Real TUS +Sham FESExperimental Treatment2 Interventions

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.

Group III: Real TUS + Real FESExperimental Treatment2 Interventions

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,165 Total Patients Enrolled

Robert ChenPrincipal InvestigatorUniversity Health Network, Toronto

2 Previous Clinical Trials

80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research undertaking recruiting geriatric patients?

"Individuals between 18 and 90 years old fulfill the eligibility criteria for this trial. Additionally, 22 trials are available to minors while 531 trials are designed specifically for elderly patients above 65."

Answered by AI

Is recruitment still available for this research endeavor?

"Affirmative. The information on clinicaltrials.gov attests that this study, which was initially published on June 13th 2023, is currently seeking patients for participation. Specifically, 15 participants need to be enrolled at a single clinic site."

Answered by AI

Am I eligible to be a part of this medical experiment?

"To qualify for the trial, candidates must have a diagnosis of parkinson's disease and fall within the age range of 18 to 90. A total of 15 participants are required in order to fulfil the requirements set out by this study."

Answered by AI

How many research participants are enrolled in this experimental investigation?

"Confirmed. According to clinicaltrials.gov, the trial is still open for enrollment since it was posted on June 13th 2023 and updated October 18th 2023; 15 individuals are required from one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Robert Chen 2023. "Effects of Peripheral Electrical Stimulation With Focused Ultrasound on Motor Symptoms in Parkinson's Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06090292.