Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

NCT07220005 | Recruiting DMC FDA Device

• 1 other identifier: Pro00117400
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Baseline, immediately after intervention, and 1 hour after intervention.

Study Arms (6)

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).

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

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

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

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

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

Device: Low intensity focused ultrasound stimulation

Interventions

Low intensity focused ultrasound stimulation DEVICE

A low-intensity focused ultrasound stimulation

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wayne Feng, MD MS

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

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

Ziping Huang, MS

CONTACT

ziping.huang@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 23, 2025
• Study Start: December 10, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)