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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at any point during or immediately following intervention on day of lifus application
Awards & highlights

LIFU Trial 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.

LIFU Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My hand muscle responds to nerve tests.
Select...
My arm and hand movement is mostly limited to one side.

LIFU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after ultrasonic stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after ultrasonic stimulation for reporting.

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

LIFU 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

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Who is running the clinical trial?

Duke UniversityLead Sponsor
2,390 Previous Clinical Trials
3,058,962 Total Patients Enrolled
21 Trials studying Stroke
218,655 Patients Enrolled for Stroke
American Heart AssociationOTHER
334 Previous Clinical Trials
4,934,025 Total Patients Enrolled
39 Trials studying Stroke
3,924,831 Patients Enrolled for Stroke
Wayne FengPrincipal InvestigatorDuke Health

Media Library

Stroke Research Study Groups: Low Intensity Focused Ultrasonic Stimulation
Stroke Clinical Trial 2023: Low Intensity Focused Ultrasonic Stimulation Highlights & Side Effects. Trial Name: NCT05016531 — N/A
~6 spots leftby Oct 2024