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RecruitingNCT07220005LIFUS-OPTIMIZEUpdated Aug 27, 2026

Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

An interventional study of Low intensity focused ultrasound stimulation in Stroke, Arm Weakness as a Consequence of Stroke and Upper Extremity Hemiparesis, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Stroke
  • Arm Weakness as a Consequence of Stroke
  • Upper Extremity Hemiparesis
  • Upper Extremity Impairments
  • Upper Extremity Weakness

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Keywords

  • Brain Stimulation
  • Transcranial Focused Ultrasound Stimulation
  • Low Intensity Focused Ultrasound Stimulation
  • Stroke Recovery
  • Motor Learning
  • Corticospinal Excitability
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 24 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Browse Duke University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • DeviceLow intensity focused ultrasound stimulation

    A low-intensity focused ultrasound stimulation

06

What researchers measure

Primary outcomes

  1. Motor sequence learning

    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).

    Time frame: Baseline, immediately after intervention, and 1 hour after intervention

  2. Corticospinal excitability

    Corticospinal excitability is measured by the peak to peak amplitude of motor evoked potential.

    Time frame: Baseline, immediately after intervention, and 1 hour after intervention.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Sep 2028, 33 months after the start.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 33 months is above that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2025
First posted
Oct 23, 2025
StartActual
Dec 10, 2025
Primary completionEst.
Sep 30, 2028
CompletionEst.
Dec 31, 2028
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07220005
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Oct 23, 2025
Start date
Dec 10, 2025
Primary completion
Sep 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Clinical Research Coordinator
Contact
megan.gonzalez@duke.edu
919-668-7597
Ziping Huang, MS
Contact
ziping.huang@duke.edu
Wayne Feng, MD MS
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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