Recruiting

LIFUS

Sponsor:

Duke University

Code:

NCT07220005

Conditions

Stroke

Arm Weakness as a Consequence of Stroke

Upper Extremity Hemiparesis

Upper Extremity Impairments

Upper Extremity Weakness

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Low intensity focused ultrasound stimulation

Study Details

Brief 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.

Conditions

Stroke

Arm Weakness as a Consequence of Stroke

Upper Extremity Hemiparesis

Upper Extremity Impairments

Upper Extremity Weakness

Study ID

NCT07220005

Start date

Dec 10, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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).

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

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

experimental: Pulse repetition frequency(PRF) at 2000 Hz

each participant will receive LIFUS with pulse repetition frequency at 2000 Hz

experimental: Pulse repetition frequency(PRF) at 1000 Hz

each participant will receive LIFUS with pulse repetition frequency at 1000 Hz

experimental: Pulse repetition frequency (PRF) at 500 Hz

Participants will receive LIFUS with pulse repetition frequency at 500 Hz

Interventions

Low intensity focused ultrasound stimulation

A low-intensity focused ultrasound stimulation

Primary outcome measure

  • Motor sequence learning [ Time Frame: Baseline, immediately after intervention, and 1 hour after intervention ]
  • Corticospinal excitability [ Time Frame: Baseline, immediately after intervention, and 1 hour after intervention. ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

919-668-7597megan.gonzalez@duke.edu

Ziping Huang, MS

ziping.huang@duke.edu

Locations

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Megan Gonzalez, MS

919-668-7597megan.gonzalez@duke.edu

More Information

Sponsor

Duke University

Last update posted

Aug 27, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-27.