← Back to Search

Other

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 below
Select...
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.
Select...
I have been diagnosed with myasthenia gravis or acute narrow angle glaucoma.
Select...
I use substances like antipsychotics, marijuana, or tobacco.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Trial 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

Low-intensity Focused Ultrasound (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04923659 — Phase < 1
Low Intensity Focused Ultrasound Research Study Groups: LIFUS
Low Intensity Focused Ultrasound Clinical Trial 2023: Low-intensity Focused Ultrasound Highlights & Side Effects. Trial Name: NCT04923659 — Phase < 1
Low-intensity Focused Ultrasound (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04923659 — Phase < 1
~2 spots leftby May 2025