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

NCT ID: NCT05016531

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2024-04-17

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Low Intensity Focused Ultrasonic Stimulation

There are different combinations of intensity and frequency with LIFUS

Group Type: EXPERIMENTAL

Low Intensity Focused Ultrasonic Stimulation

Intervention Type: DEVICE

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)

Low Intensity Focused Ultrasonic Stimulation Frequency

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. ≥ 21 years old of any gender and race;

2. Clinical ischemic stroke or hemorrhagic (confirmed by CT or MRI) that occurred >= 2 months ago

3. Predominantly unilateral motor impairment with FM-UE score ≤ 62/66;

4. MEPs are inducible from a hand muscle on the affected side (i.e. Abductor Pollicis Brevis (APB) muscle).

Exclusion Criteria

1. Any concomitant neurological disorder affecting arm function;

2. Documented history of severe dementia with or without medication before stroke;

3. Subject is unable to do the motor learning practice at the baseline;

4. 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wayne Feng

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

References

Huang Z, Charalambous CC, Chen M, Kim T, Sokhadze E, Song A, Jung SH, Shekhar S, Feld JA, Jiang X, Feng W. Low intensity focused ultrasound stimulation in stroke: A phase I safety & feasibility trial. Brain Stimul. 2025 Jan-Feb;18(1):179-187. doi: 10.1016/j.brs.2025.01.015. Epub 2025 Jan 20.

Reference Type: RESULT

PMID: 39842609 (View on PubMed)

Other Identifiers

Pro00106556

Identifier Type: -

Identifier Source: org_study_id