NCT05016531

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Aim 1 is to determine the optimal intensity of Low Intensity Focused Ultrasound stimulation (LIFUS) in stroke patients in terms of safety. We will investigate the optimal spatial-peak temporal-average intensity/ISPTA in the range of 0(or sham) W/cm2 to 8 W/cm2. Safety will be investigated by assessing clinically detectable signs and symptoms by monitoring vital signs and surveying subjects with a questionnaire before and after each stimulation session, and additionally by detecting subclinical neuronal injury using MRI/DWI. Aim 1 requires up to 36 subjects. Aim 2 is to determine the optimal frequency of LIFU stimulation in stroke patients in terms of cortical excitability. Stroke subjects undergo each of the 5 frequency levels (0.35 MHz; 0.5 MHz; 0.75 MHz, 1.0 MHz and 1.5 MHz) on 5 different days with at least one day washout. The intensity (ISPTA) will set up at the level that is determined from Aim 1. Cortical excitability is measured by the amplitude of motor evoked potentials (MEPs) induced by Transcranial Magnetic Stimulation (TMS) from the Abductor Pollicis Brevis (ABP) muscle of the affected side. MEPs will be recorded pre- and post-stimulation to determine the optimal intensity for maximal cortical excitability from the hemisphere where the lesion is located. Aim 2 requires 18 subjects.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Low Intensity Focused Ultrasonic Stimulation	Brain stimulation using ultrasonic stimulation in a sequence of increasing intensity (sham, 1 W/CM2, 2 W/CM2, 4 W/CM2, 6 W/CM2, 8 W/CM2)
DEVICE	Low Intensity Focused Ultrasonic Stimulation Frequency	Brain stimulation using ultrasonic stimulation of intensity level determined from intervention 1 at progressively increasing frequency levels (0.35 MHz; 0.5 MHz; 0.75 MHz, 1.0 MHz and 1.5 MHz)

Timeline

• Start date: 2021-10-11
• Primary completion: 2024-04-17
• Completion: 2024-04-17
• First posted: 2021-08-23
• Last updated: 2025-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study