Pedunculopontine Nucleus Transcranial Ultrasound Stimulation as a Treatment of Freezing of Gait in Parkinson's Disease
Recruiting · NCT07695233 · Interventional (participants receive a specific treatment) · Lead sponsor: Robert Chen
View the official record on ClinicalTrials.gov →Interventions studied
Excitatory StimulationInhibitory StimulationSham
What this trial is about
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 take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Toronto Western Hospital - Toronto, Ontario, Canada