Pedunculopontine Nucleus Transcranial Ultrasound Stimulation for Freezing of Gait in Parkinson's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will apply transcranial ultrasound stimulation to the Pedunculopontine nucleus in adults with Parkinson’s disease and freezing of gait. It uses a randomized, cross-over design to compare excitatory, inhibitory, and sham stimulation, with gait analyses and patient-reported outcomes to assess safety, tolerability, and impact on freezing of gait. Imaging, including rsfMRI and ASL, will examine brain connectivity and perfusion changes, and structural MRI will guide individualized stimulation parameters. The study enrolls 25 PD patients with FOG and 25 matched healthy controls to characterize effects and mechanisms. Primary outcomes focus on gait metrics and quality of life, while secondary analyses explore functional connectivity and safety signals via MRI.

Why it matters

Who can join: the full rules

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

Where it's running

• Toronto Western Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Robert Chen, MD — University Health Network, Toronto
• Study coordinator: Julian Kwok
• Email: julian.kwok@uhn.ca
• Phone: 416-603-5800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.