Trial Outcomes & Findings for Optimizing Parameters of Low-Intensity Focused Ultrasound for Cortical Modulation in Stroke Patients (NCT NCT05016531)

Last Updated: 2026-08-07

Results Overview

A "major response" is pre-defined as having any of the following events: Second degree scalp burn; Clinical seizure; New lesion on DWI sequence of MRI scan and the lesion not explained by any other cause(s) or decreased ADC under the transducer stimulating motor cortex area; Patient discontinues from the study due to any reason.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

At any point during or immediately following intervention on day of LIFUS application

Results posted on

2026-08-07

Participant Flow

Unable to complete Aim 2. No Aim 2 participants were enrolled.

Participant milestones

Participant milestones
Measure	Aim 1: Sham, Then 1 W/cm^2, Then 2 W/cm^2, Then 4 W/cm^2, Then 6 W/cm^2, Then 8 W/cm^2 Stimulation There are different combinations of intensity and frequency with LIFUS Low Intensity Focused Ultrasound Stimulation: Brain stimulation using ultrasonic stimulation in a sequence of increasing intensity (sham, 1 W/cm\^2, 2 W/cm\^2, 4 W/cm\^2, 6 W/cm\^2, 8 W/cm\^2)
Overall Study STARTED	18
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aim 1: Sham, Then 1 W/cm^2, Then 2 W/cm^2, Then 4 W/cm^2, Then 6 W/cm^2, Then 8 W/cm^2 Stimulation n=18 Participants Low Intensity Focused Ultrasound Stimulation: Brain stimulation using ultrasonic stimulation in a sequence of increasing intensity (sham, 1 W/cm\^2, 2 W/cm\^2, 4 W/cm\^2, 6 W/cm\^2, 8 W/cm\^2)
Age, Continuous	52 years STANDARD_DEVIATION 14 • n=20 Participants
Sex: Female, Male Female	6 Participants n=20 Participants
Sex: Female, Male Male	12 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	8 Participants n=20 Participants
Race (NIH/OMB) White	9 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Region of Enrollment United States	18 Participants n=20 Participants

PRIMARY outcome

Timeframe: At any point during or immediately following intervention on day of LIFUS application

Population: Unable to complete Aim 2. No Aim 2 participants were enrolled.

Outcome measures

Outcome measures
Measure	Aim 1: Sham, Then 1 W/cm^2, Then 2 W/cm^2, Then 4 W/cm^2, Then 6 W/cm^2, Then 8 W/cm^2 Stimulation n=18 Participants There are different combinations of intensity and frequency with LIFUS (Low Intensity Focused Ultrasound Stimulation): Brain stimulation using ultrasonic stimulation in a sequence of increasing intensity (sham, 1 W/cm\^2, 2 W/cm\^2, 4 W/cm\^2, 6 W/cm\^2, 8 W/cm\^2)
Safety Outcomes as Measured by the Number of Participants With a "Major Response"	0 Participants

SECONDARY outcome

Timeframe: Immediately after ultrasonic stimulation

Population: Unable to complete Aim 2. No Aim 2 participants were enrolled.

Cortical excitability is measured by Motor evoked potential(MEP) amplitude using Transcranial Magnetic Stimulation. The median amplitude of all MEPs was calculated and used as the measure of the corticospinal excitability. The percentage change in MEP (post-pre) was calculated and the number of participants who improved by ≥20 % on MEP amplitude is reported.

Outcome measures

Outcome measures
Measure	Aim 1: Sham, Then 1 W/cm^2, Then 2 W/cm^2, Then 4 W/cm^2, Then 6 W/cm^2, Then 8 W/cm^2 Stimulation n=18 Participants There are different combinations of intensity and frequency with LIFUS (Low Intensity Focused Ultrasound Stimulation): Brain stimulation using ultrasonic stimulation in a sequence of increasing intensity (sham, 1 W/cm\^2, 2 W/cm\^2, 4 W/cm\^2, 6 W/cm\^2, 8 W/cm\^2)
Cortical Excitability as Measured by the Number of Participants Who Improved by ≥ 20% on Motor Evoked Potential (MEP) Amplitude	12 Participants

SECONDARY outcome

Timeframe: Immediately after ultrasonic stimulation

Population: Unable to complete Aim 2. No Aim 2 participants were enrolled.

MSL improvements is quantified by calculating the percentage change in the median response time (post-pre) and the number of participants who improved by ≥20 % on MSL is reported.