Exploring how low-intensity focused ultrasound affects brain plasticity
Pharmacological Mechanisms of Low-intensity Focused Ultrasound for Motor Cortex Neuroplasticity
This study is testing how low-intensity focused ultrasound combined with certain medications can change brain activity and help the brain adapt in healthy adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04923659 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacological mechanisms of low-intensity focused ultrasound (LIFUS) on motor cortex neuroplasticity in healthy adults. It aims to understand how LIFUS interacts with neurotransmitter receptors and ion channels by administering various brain-active drugs alongside ultrasound stimulation. Participants will undergo five double-blind sessions where they will receive either a drug or placebo to assess the effects on cortical activity and neuroplasticity. The study will provide insights into the dynamic processes involved in brain signaling and plasticity induced by LIFUS.
Who should consider this trial
Good fit: Ideal candidates are right-handed healthy adults aged 18-65 without any major neurological or musculoskeletal disorders.
Not a fit: Patients with diagnosed neurological diseases, major psychiatric disorders, or those with contraindications to ultrasound stimulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of non-invasive brain stimulation techniques, potentially leading to improved treatments for neurological disorders.
How similar studies have performed: While LIFUS has shown promise in previous studies, this specific investigation into its pharmacological mechanisms is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Right-handed healthy subjects between the ages of 18-65 will be included for recruitment. Exclusion Criteria: * Diagnosed with any gait or postural disorders * Major neurological disease or disorder * Major musculoskeletal or nerve disorder, or disorder of hands, wrists and upper limbs * History of stroke or seizure * Diagnosed with dementia * Diagnosed with myasthenia gravis or acute narrow angle glaucoma * Has intracranial implant(s) or device(s) * Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD) * Presence of metal implanted in body that is contraindicated in TMS * Caffeine or chocolate consumption 1-2 hours before study sessions * Consumption of grapefruit juice 24 hours before study sessions * Alcohol consumption 24 hours before study sessions * 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 * Regular usage of CNS active drugs or calcium channel blockers during or up to 2 weeks before participating in the study\*\* * Is on antipsychotics, marijuana, or other recreational drugs (including tobacco) that affect the nervous system * Major cardiac, hematopoietic, liver, or kidney disease or infection * Treated hypertension * Hypersensitivity to benzodiazepines * Hypersensitivity to calcium channel blockers * Hypersensitivity to antitussives * Hypersensitivity to anticonvulsants * Regular usage of androgens, antibiotics, antifungals, antivirals, cardiovascular/gastrointestinal drugs, muscle relaxants, and platelet aggregation inhibitors during or up to 2 weeks before participating in the study
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: Tasnuva Hoque, BSc
- Email: tasnuva.hoque@uhnresearch.ca
- Phone: 16476887464
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.