Optimizing Parameters of Low-Intensity Focused Ultrasound for Cortical Modulation in Stroke Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Stroke

In brief

The purpose of this research study is to find out the optimal intensity and frequency of Low Intensity Focused Ultrasound (LIFU) that is safe and tolerable in people who have had a stroke.

Key facts

Study ID

NCT05016531

Run by

Duke University

People needed

18

Starts

2021-10-11

Expected to finish

2024-04-17

Last updated by the study team

2026-08-07

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 21 years old of any gender and race;
• Clinical ischemic stroke or hemorrhagic (confirmed by CT or MRI) that occurred >= 2 months ago
• Predominantly unilateral motor impairment with FM-UE score ≤ 62/66;
• MEPs are inducible from a hand muscle on the affected side (i.e. Abductor Pollicis Brevis (APB) muscle).

You may not qualify if…

• Any concomitant neurological disorder affecting arm function;
• Documented history of severe dementia with or without medication before stroke;
• Subject is unable to do the motor learning practice at the baseline;
• Presence of any MRI/TMS/ultrasonic stimulation risk factors: an electrically, magnetically, or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips, or any other electrically sensitive support system; non-fixed metal in any part of the body; pregnancy (the effect of TMS/ultrasonic stimulation on the fetus is unknown); no history of seizure before or after the stroke; preexisting scalp lesion or wound or bone defect or hemicraniectomy.

Where it is running

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

Full record on ClinicalTrials.gov

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