StrokeLIFUS-OPTIMIZENCT07220005
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
A study testing Low intensity focused ultrasound stimulation in people with Stroke and Arm Weakness as a Consequence of Stroke, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Arm Weakness as a Consequence of Stroke, Upper Extremity Hemiparesis
- What is being tested?
- Low intensity focused ultrasound stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Concurrent enrollment in another interventional stroke recovery study
- Concerns that the subject cannot comply with study procedures and visits
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ziping Huang, MS contact
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Megan Gonzalez, MS, 919-668-7597, megan.gonzalez@duke.edu
About this study
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.
- Conditions
- Stroke, Arm Weakness as a Consequence of Stroke, Upper Extremity Hemiparesis, Upper Extremity Impairments, Upper Extremity Weakness
- Being tested
- Low intensity focused ultrasound stimulation
- Keywords
- Brain Stimulation, Transcranial Focused Ultrasound Stimulation, Low Intensity Focused Ultrasound Stimulation, Stroke Recovery, Motor Learning, Corticospinal Excitability
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity focused ultrasound stimulationDevice
A low-intensity focused ultrasound stimulation
| Study group | Role | What they receive |
|---|---|---|
| ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities) | Experimental | Participant will receive ultrasound stimulation at intensity of 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities, ISPPA). Receives: Device: Low intensity focused ultrasound stimulation |
| ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities) | Experimental | Participant will receive ultrasound stimulation at intensity of ISPPA of 4 W/cm^2 Receives: Device: Low intensity focused ultrasound stimulation |
| Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities) | Sham comparator | Participant will receive ultrasound stimulation at ISPPA- 0 W/cm^2 or sham stimulation Receives: Device: Low intensity focused ultrasound stimulation |
| Pulse repetition frequency(PRF) at 2000 Hz | Experimental | each participant will receive LIFUS with pulse repetition frequency at 2000 Hz Receives: Device: Low intensity focused ultrasound stimulation |
| Pulse repetition frequency(PRF) at 1000 Hz | Experimental | each participant will receive LIFUS with pulse repetition frequency at 1000 Hz Receives: Device: Low intensity focused ultrasound stimulation |
| Pulse repetition frequency (PRF) at 500 Hz | Experimental | Participants will receive LIFUS with pulse repetition frequency at 500 Hz Receives: Device: Low intensity focused ultrasound stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, immediately after intervention, and 1 hour after intervention
Corticospinal excitability
Corticospinal excitability is measured by the peak to peak amplitude of motor evoked potential.
Measured: Baseline, immediately after intervention, and 1 hour after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start10 Dec 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wayne Feng, MD MS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220005
- Sponsor's protocol ID
- Pro00117400
- Other IDs
- 26PRE1544441
- Acronym
- LIFUS-OPTIMIZE
- Status last verified
- Dec 2025
- First submitted
- 21 Oct 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
- ClinicalTrials.gov ID
- NCT07220005
- Acronym / sponsor ID
- LIFUS-OPTIMIZE / Pro00117400
- Conditions
- Stroke, Arm Weakness as a Consequence of Stroke, Upper Extremity Hemiparesis, Upper Extremity Impairments, Upper Extremity Weakness
- Keywords
- Brain Stimulation, Transcranial Focused Ultrasound Stimulation, Low Intensity Focused Ultrasound Stimulation, Stroke Recovery, Motor Learning, Corticospinal Excitability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities) | Experimental | Device: Low intensity focused ultrasound stimulationParticipant will receive ultrasound stimulation at intensity of 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities, ISPPA). |
| ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities) | Experimental | Device: Low intensity focused ultrasound stimulationParticipant will receive ultrasound stimulation at intensity of ISPPA of 4 W/cm^2 |
| Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities) | Sham comparator | Device: Low intensity focused ultrasound stimulationParticipant will receive ultrasound stimulation at ISPPA- 0 W/cm^2 or sham stimulation |
| Pulse repetition frequency(PRF) at 2000 Hz | Experimental | Device: Low intensity focused ultrasound stimulationeach participant will receive LIFUS with pulse repetition frequency at 2000 Hz |
| Pulse repetition frequency(PRF) at 1000 Hz | Experimental | Device: Low intensity focused ultrasound stimulationeach participant will receive LIFUS with pulse repetition frequency at 1000 Hz |
| Pulse repetition frequency (PRF) at 500 Hz | Experimental | Device: Low intensity focused ultrasound stimulationParticipants will receive LIFUS with pulse repetition frequency at 500 Hz |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity focused ultrasound stimulationA low-intensity focused ultrasound stimulation | Device | Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities), ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities), ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities), Pulse repetition frequency (PRF) at 500 Hz, Pulse repetition frequency(PRF) at 1000 Hz, Pulse repetition frequency(PRF) at 2000 Hz |
Primary outcome
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ziping Huang, MS contact
Wayne Feng, MD MS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity focused ultrasound stimulation in people with Stroke and Arm Weakness as a Consequence of Stroke, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (919-668-7597, megan.gonzalez@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor sequence learning (time frame: Baseline, immediately after intervention, and 1 hour after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.