Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization (LIFUS-OPTIMIZE)

Duke University

Status: Enrolling

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

Treatments: Device: Low intensity focused ultrasound stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07220005

Pro00117400

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 6 patient groups

ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)

Experimental group

Description:

Participant will receive ultrasound stimulation at intensity of 8 W/cm\^2 (estimated intracranial spatial-peak pulse-average intensities, ISPPA).

Treatment:

Device: Low intensity focused ultrasound stimulation

ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)

Experimental group

Description:

Participant will receive ultrasound stimulation at intensity of ISPPA of 4 W/cm\^2

Treatment:

Device: Low intensity focused ultrasound stimulation

Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)

Sham Comparator group

Description:

Participant will receive ultrasound stimulation at ISPPA- 0 W/cm\^2 or sham stimulation

Treatment:

Device: Low intensity focused ultrasound stimulation

Pulse repetition frequency(PRF) at 2000 Hz

Experimental group

Description:

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

Treatment:

Device: Low intensity focused ultrasound stimulation

Pulse repetition frequency(PRF) at 1000 Hz

Experimental group

Description:

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

Treatment:

Device: Low intensity focused ultrasound stimulation

Pulse repetition frequency (PRF) at 500 Hz

Experimental group

Description:

Participants will receive LIFUS with pulse repetition frequency at 500 Hz

Treatment:

Device: Low intensity focused ultrasound stimulation