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Ultrasound Therapy
Low-Intensity Focused Ultrasound for Stroke (LIFU Trial)
N/A
Recruiting
Led By Wayne Feng
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
MEPs are inducible from a hand muscle on the affected side (i.e. Abductor Pollicis Brevis (APB) muscle)
Predominantly unilateral motor impairment with FM-UE score ≤ 62/66
Must not have
Any concomitant neurological disorder affecting arm function
Subject is unable to do the motor learning practice at the baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at any point during or immediately following intervention on day of lifus application
Awards & highlights
Summary
This trial is testing different intensities and frequencies of ultrasound to find a safe and tolerable option for stroke patients.
Who is the study for?
This trial is for adults over 21 who have had a stroke confirmed by CT or MRI at least 2 months ago, with mainly one-sided motor issues and can still induce muscle responses in the affected hand. It's not for those with other neurological disorders affecting arm function, severe pre-stroke dementia, inability to practice motor skills, or risks from MRI/TMS/ultrasound like metal implants or pregnancy.Check my eligibility
What is being tested?
The study aims to determine the safest and most tolerable settings for Low Intensity Focused Ultrasound (LIFU) therapy in stroke patients. Researchers will adjust the intensity and frequency of LIFU to find optimal parameters that could help improve cortical modulation after a stroke.See study design
What are the potential side effects?
While specific side effects are not listed, LIFU may potentially cause discomfort at the stimulation site, headache, or skin irritation. Since it's non-invasive and focuses on brain modulation post-stroke, serious side effects are unlikely but will be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hand muscle responds to nerve tests.
Select...
My arm and hand movement is mostly limited to one side.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a nerve condition that affects my arm's movement.
Select...
I cannot perform motor learning exercises currently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after ultrasonic stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after ultrasonic stimulation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cortical Excitability - Aim 2 of the study
Safety Outcomes, as measured by the number of participants with a "major response" - Aim 1 of study
Trial Design
1Treatment groups
Experimental Treatment
Group I: Low Intensity Focused Ultrasonic StimulationExperimental Treatment2 Interventions
There are different combinations of intensity and frequency with LIFUS
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,394 Previous Clinical Trials
3,059,432 Total Patients Enrolled
21 Trials studying Stroke
218,655 Patients Enrolled for Stroke
American Heart AssociationOTHER
336 Previous Clinical Trials
4,935,090 Total Patients Enrolled
39 Trials studying Stroke
3,924,831 Patients Enrolled for Stroke
Wayne FengPrincipal InvestigatorDuke Health
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Low Intensity Focused Ultrasonic Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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