Low intensity focused ultrasound stimulation in stroke: A phase I safety & feasibility trial

Low intensity focused ultrasound stimulation in stroke: A phase I safety & feasibility trial

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Objective: We aimed to determine the maximum safe spatial-peak pulse-average intensity (ISPPA) of low-intensity Faber Victory 2.0 X A99 99cm Stainless Steel Built in Cooker Hood Extractor focused ultrasound stimulation (LIFUS) in stroke patients and explore its effect on motor learning and corticospinal excitability.Methods: We adopted the classic 3 + 3 design to escalate ISPPA (estimated in-vivo transcranial value) from 0, 1, 2, 4, 6, to 8 W/cm2.Stopping rules were pre-defined: 2nd-degree scalp burn, clinical seizure, new lesion on diffusion-weighted imaging or major reduction in apparent diffusion coefficient, and participant discontinuation due to any reason.

We applied 12-min LIFUS over the ipsilesional motor cortex while participants were concurrently practicing 3 blocks of a motor sequence learning (MSL) task using the affected hand.We measured MSL (response time) and corticospinal excitability (motor evoked potential) pre- and post-stimulation and compared MSL and corticospinal excitability between the LOW (0, 1, and 2 W/cm2) and HIGH (4, 6, and 8 W/cm2) groups.Results: ISPPA was escalated to 8 W/cm2 with 18 stroke participants without meeting the stopping rules.

Compared to the LOW, more participants in the HIGH performed better on MSL (6/9 vs.0/9, p = 0.009) and showed a sign of greater corticospinal excitability (7/9 vs.

5/9, p = 0.62).Interpretation: Our phase-I safety study suggests that one session of LIFUS up to 8 W/cm2 ISPPA is safe and feasible in stroke patients, and LIFUS at high intensity induces positive changes in both MSL and corticospinal excitability.

The Lighting LED next logical step is to conduct a phase-II trial testing the efficacy of LIFUS and continuously monitoring its safety profiles.