Low-intensity focused ultrasound for movement and seizure disorders
Clinical Effects of Low-Intensity Focused Ultrasound Neuromodulation in Patients With Neurological and Psychiatric Disorders
NA · University Health Network, Toronto · NCT07417280
This trial will try low-intensity focused ultrasound (LIFUS) to see if it can safely change brain activity in people with movement disorders or epilepsy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07417280 on ClinicalTrials.gov |
What this trial studies
Low-intensity focused ultrasound (LIFUS) is a noninvasive method that delivers focused acoustic energy to targeted brain regions to modulate neuronal excitability. In this interventional protocol, participants with movement disorders or epilepsy will receive either LIFUS or sham LIFUS while investigators measure changes in brain excitability and related neurophysiologic markers. Prior work in healthy volunteers showed mild reductions in motor cortex excitability, and this trial applies the technique to patients to characterize effects and safety. Participants are screened for contraindications such as implanted metal, low cognitive scores, pregnancy, or major systemic illness.
Who should consider this trial
Good fit: Adults aged 18–85 with Parkinson's disease, essential tremor, orthostatic tremor, dystonia, or epilepsy who meet cognitive and safety criteria (e.g., MoCA ≥22, no contraindicated implants, not pregnant) are ideal candidates.
Not a fit: Patients with a history of stroke, comorbid dementia or MoCA <22, contraindicated implants (pacemaker/ICD or certain metal), pregnancy, major systemic illness, or on interfering psychotropic/recreational substances are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, LIFUS could offer a noninvasive way to reduce abnormal brain excitability and potentially improve symptoms in movement disorders and epilepsy.
How similar studies have performed: Early studies in healthy volunteers have shown mild reductions in motor cortex excitability with LIFUS, but clinical benefit in patient populations remains unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-85 years of age * Patients diagnosed with neurological disorders, (such as epilepsy, brain tumour, movement disorders) or psychiatric disorders (such as substance abuse disorder) * Patients undergoing medical or surgical treatment (such as DBS) for neurological disorders Exclusion Criteria: * History of stroke * Comorbid dementia * Scored below 22 on the Montreal Cognitive Assessment (MoCA) * Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD) * 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 * Receiving a psychotropic medication or taking recreational substances that in the opinion of the investigator will significantly affect safety of the protocol * Major systemic illness or infection
Where this trial is running
Toronto, Ontario
- Toronto Western Hospital, 399 Bathurst St — Toronto, Ontario, Canada (RECRUITING)
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.
Conditions: Parkinson's Disease, Essential Tremor, Orthostatic Tremor, Dystonia, Epilepsy, Substance Abuse Disorder, Deep Brain Stimulation, DBS