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Pharmacological Agents for Enhancing Low-Intensity Focused Ultrasound Effects (LIFUS-Pharma Trial)
Phase < 1
Recruiting
Led By Robert Chen, MBBS
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Right-handed healthy subjects between the ages of 18-65 will be included for recruitment.
Be older than 18 years old
Must not have
Major cardiac, hematopoietic, liver, or kidney disease or infection
History of stroke or seizure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Summary
This trial is exploring the effect of low-intensity focused ultrasound on specific receptors and channels in the motor cortex, in order to better understand how this non-invasive brain stimulation technique works.
Who is the study for?
Healthy right-handed individuals aged 18-65 can join this trial. They must not be using antipsychotics, recreational drugs, CNS active drugs, or certain other medications recently. People with major diseases (cardiac, liver, kidney), neurological disorders, gait issues, mental health conditions that affect study compliance or those who are pregnant cannot participate.
What is being tested?
The trial is testing how low-intensity focused ultrasound affects the motor cortex when combined with different brain-active drugs: Carbamazepine, Lorazepam, Dextromethorphan, Nimodipine and a placebo. Each participant will undergo five sessions to see how these substances influence brain stimulation outcomes.
What are the potential side effects?
Possible side effects from the drugs may include dizziness and drowsiness from Lorazepam; nausea and confusion from Carbamazepine; potential memory problems from Dextromethorphan; and headaches or swelling in the legs due to Nimodipine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am right-handed, healthy, and aged between 18-65.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have major heart, blood, liver, or kidney diseases or infections.
Select...
I have had a stroke or seizure in the past.
Select...
I do not have any major neurological diseases.
Select...
I have been diagnosed with a walking or posture disorder.
Select...
I have a significant condition affecting my muscles, nerves, hands, wrists, or arms.
Select...
I have been diagnosed with dementia.
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I have been diagnosed with myasthenia gravis or acute narrow angle glaucoma.
Select...
I use substances like antipsychotics, marijuana, or tobacco.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intracortical Facilitation
Motor Evoked Potential
Recruitment Curve
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: LIFUSExperimental Treatment5 Interventions
Low Intensity Focussed ultrasound.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbamazepine
2016
Completed Phase 4
~2690
Lorazepam
2009
Completed Phase 4
~2660
Dextromethorphan
2019
Completed Phase 4
~920
Nimodipine
2013
Completed Phase 4
~260
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,524 Previous Clinical Trials
503,184 Total Patients Enrolled
Robert Chen, MBBSPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been using medications like antibiotics or muscle relaxants regularly up to 2 weeks before the study.I do not have major heart, blood, liver, or kidney diseases or infections.I have had a stroke or seizure in the past.I am receiving treatment for high blood pressure.I am right-handed, healthy, and aged between 18-65.I do not have any major neurological diseases.I haven't taken CNS active drugs or calcium channel blockers in the last 2 weeks.I have been diagnosed with a walking or posture disorder.I have a significant condition affecting my muscles, nerves, hands, wrists, or arms.I have been diagnosed with dementia.I have been diagnosed with myasthenia gravis or acute narrow angle glaucoma.I use substances like antipsychotics, marijuana, or tobacco.
Research Study Groups:
This trial has the following groups:- Group 1: LIFUS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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