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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

LIFUS-Pharma Trial 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.Check my eligibility
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.See study design
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.

LIFUS-Pharma Trial 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.

LIFUS-Pharma Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intracortical Facilitation
Motor Evoked Potential
Recruitment Curve
+2 more

LIFUS-Pharma 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
1,468 Previous Clinical Trials
484,470 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could elderly individuals over 80 years meet the criteria for this scientific experiment?

"As per the eligibility requirements, individuals enrolling in this trial should be aged between 18 and 65. There are 5 medical studies for children below 18 years old and 19 research programs that cater to adults over 65."

Answered by AI

How many participants are contributing to this research endeavor?

"Affirmative. Clinicaltrials.gov data asserts that this medical experiment, which was first advertised on May 25th 2021, is actively recruiting participants. A total of 20 people need to be enrolled from 1 trial location."

Answered by AI

Is enrollment for this research project still open?

"Affirmative, there is information on clinicaltrials.gov that indicates this medical trial is actively recruiting participants. The initial posting was made May 25th 2021 with the most recent update occurring on May 18th 2022; 20 patients are needed at a single enrolment site."

Answered by AI

What therapeutic purposes is Carbamazepine commonly used for?

"Traditionally, carbamazepine is utilized to treat partial seizures with secondary generalization. However, this drug can also be used for the management of restless legs syndrome (RLS), pain relief, and other forms of pharmacotherapy."

Answered by AI

Are my qualifications apt for enrolling in this medical experiment?

"This research is opening its doors to 20 individuals that use ultrasonography and are 18-65 years old. All applicants must meet the following criteria: Right-handed subjects within this age range who are in good health will be considered for enrollment."

Answered by AI
~5 spots leftby May 2025