RecruitingNot Applicable

Pedunculopontine Nucleus Transcranial Ultrasound Stimulation as a Treatment of Freezing of Gait in Parkinson's Disease

Canada50 participantsStarted 2024-05-17

Plain-language summary

This study is investigating the use of transcranial ultrasound stimulation (TUS) on the Pedunculopontine nucleus (PPN) in changing freezing of gait in people with Parkinson's disease. The PPN is noted to be involved in voluntary movements, locomotion, and muscle tone. This will be assessed by patient-reported outcomes and analyzing the gait. The study will also investigate the effects of the stimulation on the PPN and surrounding connectivity by using magnetic resonance imaging (MRI).

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-90 years of age * Confirmed diagnosis of a movement disorder with Freezing of Gait * Stable dopaminergic medication dose for a minimum of 4 weeks 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 DBS system in place. * Presence of metal implanted in body that is contraindicated in TMS/MRI * 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, marijuana, or other recreational drugs that affect the nervous system * Major musculoskeletal or neuromuscular disease or disorder of the hands, wrists and limbs * Major systemic illness or infection

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

New Freezing of Gait Questionnaire

Timeframe: Occurs twice at Visits 2, 3, and 4. For each of those visits, it will be conducted once before stimulation and another after stimulation.

Timed Up-and-Go Task

Timeframe: Occurs twice at Visits 2, 3, and 4. For each of those visits, it will be conducted once before stimulation and another after stimulation.

ZenoTM Walkway

Timeframe: Occurs twice at Visits 2, 3, and 4. For each of those visits, it will be conducted once before stimulation and another after stimulation.

Trial details

NCT IDNCT07695233

SponsorRobert Chen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Julian Kwok

416-603-5800 julian.kwok@uhn.ca

View on ClinicalTrials.gov More Parkinson Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

New Freezing of Gait Questionnaire

Timeframe: Occurs twice at Visits 2, 3, and 4. For each of those visits, it will be conducted once before stimulation and another after stimulation.

Timed Up-and-Go Task

Timeframe: Occurs twice at Visits 2, 3, and 4. For each of those visits, it will be conducted once before stimulation and another after stimulation.

ZenoTM Walkway

Timeframe: Occurs twice at Visits 2, 3, and 4. For each of those visits, it will be conducted once before stimulation and another after stimulation.