Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization (LIFUS-OPTIMIZE)

August 25, 2026 updated by: Duke University

The goal of this research study is to optimize the parameter of Low-Intensity Focused Ultrasound Stimulation (LIFUS) that is most effective in changing cortical excitability and motor learning skills in patients who suffered a stroke. The researchers hope to answer two questions.

  • with increasing power, would LIFUS be more effective?
  • with the same power, what LIFUS timing is the best

For Aim 1, the study will compare 8, 4 W/cm^2 to a zero(sham) stimulation to see if higher power is the better.

For Aim 2, the study will compare 500 vs 1000 vs 2000 Hz "timing" to see which one is better.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age >=21 years old of any gender or race
  • First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from the stroke onset of symptoms
  • Unilateral arm weakness measured by the Fugl-Meyer Upper-Extremity Scale ≤ 62/64
  • Inducible resting motor threshold and testing motor threshold recorded from an affected upper extremity muscle

Exclusion Criteria:

  • Bilateral strokes (infarcts and/or hematoma)
  • Other co-existent neuromuscular disorders affecting upper extremity motor impairment
  • History of medically uncontrolled depression or other neuropsychiatric disorders despite medications either before or after a stroke that may affect the subject's ability to participate in the study
  • History of confirmed dementia or taking dementia drugs
  • Uncontrolled hypertension despite medical treatment(s) at the time of enrollment, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and enrolled later)
  • Presence of any MRI/TMS/LIFUS risk factors
  • Concurrent enrollment in another interventional stroke recovery study
  • Concerns that the subject cannot comply with study procedures and visits
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
Participant will receive ultrasound stimulation at intensity of 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities, ISPPA).
Device: Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Experimental: ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
Participant will receive ultrasound stimulation at intensity of ISPPA of 4 W/cm^2
Device: Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Sham Comparator: Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
Participant will receive ultrasound stimulation at ISPPA- 0 W/cm^2 or sham stimulation
Device: Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Experimental: Pulse repetition frequency(PRF) at 2000 Hz
each participant will receive LIFUS with pulse repetition frequency at 2000 Hz
Device: Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Experimental: Pulse repetition frequency(PRF) at 1000 Hz
each participant will receive LIFUS with pulse repetition frequency at 1000 Hz
Device: Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation
Experimental: Pulse repetition frequency (PRF) at 500 Hz
Participants will receive LIFUS with pulse repetition frequency at 500 Hz
Device: Low intensity focused ultrasound stimulation
A low-intensity focused ultrasound stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor sequence learning
Time Frame: Baseline, immediately after intervention, and 1 hour after intervention
Motor sequence learning (MSL) involves predictive processing that results in the anticipation of each component of a sequence of actions. MSL will produce response times and the MSL measure will be the number of responders (i.e., those with ≥20% reduction in the response time).
Baseline, immediately after intervention, and 1 hour after intervention
Corticospinal excitability
Time Frame: Baseline, immediately after intervention, and 1 hour after intervention.
Corticospinal excitability is measured by the peak to peak amplitude of motor evoked potential.
Baseline, immediately after intervention, and 1 hour after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Wayne Feng, MD MS, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 21, 2025

First Submitted That Met QC Criteria

October 21, 2025

First Posted (Actual)

October 23, 2025

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00117400
  • 26PRE1544441 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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