Optimizing low-intensity focused ultrasound to improve arm movement after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study delivers low-intensity transcranial focused ultrasound (LIFUS) to the motor cortex of chronic stroke survivors with unilateral upper-extremity weakness to identify stimulation settings that alter cortical excitability and motor learning. In Aim 1 participants receive 8 W/cm^2, 4 W/cm^2, or sham stimulation to test the effect of power, and in Aim 2 the study compares pulse timing at 500, 1000, and 2000 Hz at the same power to determine optimal timing. Primary outcomes include changes in cortical excitability (motor thresholds) and performance on motor-learning tasks. All procedures are conducted at Duke University Hospital and require in-person visits.

Why it matters

Who can join: the full rules

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

Where it's running

• Duke University Hospital
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Wayne Feng, MD MS — Duke University
• Study coordinator: Clinical Research Coordinator
• Email: megan.gonzalez@duke.edu
• Phone: 919-668-7597

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.