Combining ultrasound and electrical stimulation to improve motor symptoms in Parkinson's patients
Investigating the Effects of Peripheral Electrical Stimulation in Combination With Low Intensity Focused Ultrasound for Upper Extremity Motor Symptoms in Patients With Parkinson Disease (PD)
This study is testing if combining ultrasound and electrical stimulation can help improve movement problems in people with Parkinson's disease while they continue their regular medication.
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 | NCT06090292 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of combining transcranial ultrasound stimulation (TUS) with functional electrical stimulation (FES) on motor symptoms in patients with Parkinson's disease. Participants will undergo three study visits, each involving different combinations of real and sham TUS and FES treatments. The aim is to assess the neuromodulatory effects of these combined therapies on motor function, while patients remain on stable dopaminergic medication. Each treatment session will involve targeted stimulation of specific hand muscles during functional tasks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 with a confirmed diagnosis of Parkinson's disease who have been on a stable dose of dopaminergic medication for at least four weeks.
Not a fit: Patients with a history of stroke, seizure, or significant cognitive impairment, as well as those with certain medical implants or psychiatric disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved motor function and quality of life for patients with Parkinson's disease.
How similar studies have performed: While the combination of TUS and FES has not been previously studied in this context, both techniques have shown promise individually in improving motor function in various conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-90 years of age * Confirmed diagnosis of Parkinson's disease * Stable dopaminergic medication dose for a minimum of 4 weeks (applicable for PD patients only) 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 system in place. * Presence of metal implanted in body that is contraindicated in TMS/MRI/peripheral electrical stimulation * 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, anti-depressants, marijuana, or other recreational drugs that affect the nervous system * Major musculoskeletal or neuromuscular disease or disorder of the hands, wrists and limbs * Severe Dyskinesia * Genetic mutations * 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 — 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.