← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after ultrasonic stimulation

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,432 Total Patients Enrolled

20 Trials studying Stroke

216,655 Patients Enrolled for Stroke

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,572 Total Patients Enrolled

39 Trials studying Stroke

3,925,019 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

Frequently Asked Questions

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

Does this trial currently have room for participants?

"Affirmative. Per the data on clinicaltrials.gov, this trial is actively recruiting patients who meet its criteria and whose application has been accepted. This research project was first posted on October 11th 2021 and it's most recent update came out November 30th 2022; 54 participants are being sought at 1 location for enrolment."

Answered by AI

How many individuals are currently enrolled in this research endeavor?

"Correct. Clinicaltrials.gov reveals that this experiment, which was first published on October 11th 2021, is actively recruiting participants. 54 individuals will be accepted from a single research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Parameters of Low-Intensity Focused Ultrasound for Cortical Modulation in Stroke Patients

2021. "Optimizing Parameters of Low-Intensity Focused Ultrasound for Cortical Modulation in Stroke Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05016531.