Using focused ultrasound to treat primary orthostatic tremor
Modulating Dysfunctional Cerebellar Activity With Low-intensity Focused Ultrasound Stimulation for Primary Orthostatic Tremor
This study is testing whether a new treatment using focused ultrasound can help people with primary orthostatic tremor feel better by targeting a specific part of the brain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05547620 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of low-intensity focused ultrasound (LIFUS) to modulate cerebellar activity in patients with primary orthostatic tremor (POT). By targeting the cerebellum with high spatial precision, the study aims to alleviate the symptoms associated with this rare movement disorder. Participants will undergo MRI scans to accurately position the ultrasound transducer, followed by LIFUS sessions to assess its effects on tremor symptoms and brain connectivity. The study will include 15 patients who will participate in three in-lab sessions to evaluate the efficacy of this novel treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-90 with a confirmed diagnosis of primary orthostatic tremor.
Not a fit: Patients with a history of stroke, seizure, or other significant neurological or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce tremor symptoms and improve quality of life for patients with primary orthostatic tremor.
How similar studies have performed: While LIFUS is a novel approach, other studies have shown promise in using focused ultrasound for brain modulation, indicating potential for success in this application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-90 years of age * Confirmed diagnosis of orthostatic tremor 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 (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 this trial is running
Toronto, Ontario
- Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Robert Chen, MBBS — University Health Network, Toronto
- Study coordinator: Julian Kwok
- Email: julian.kwok@uhn.ca
- Phone: 1 416 603 5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.