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NCT Number: NCT07220005

Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

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.

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Key information

Conditions

Stroke Arm Weakness as a Consequence of Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Extremity Hemiparesis Upper Extremity Impairments Upper Extremity Weakness Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Megan Gonzalez, MS

CONTACT

[email protected]

919-668-7597

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 rest motor threshold and testing motor threshold recorded from the affected abductor pollicis brevis 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

Treatment and study plan

Low intensity focused ultrasound stimulation

Device

A low-intensity focused ultrasound stimulation

Primary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Coordinator

CONTACT

[email protected]

919-668-7597

Ziping Huang, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: LIFUS-OPTIMIZE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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