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

NCT05016531 | Completed DMC FDA Device

• 1 other identifier: Pro00106556
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

low intensity focused ultrasound; stroke; brain stimulation; ultrasonic stimulation

Outcome Measures

Primary Outcomes (2)

• Safety Outcomes, as measured by the number of participants with a "major response" - Aim 1 of study

  Safety outcomes are measured by "major response" which is pre-defined by any of the following event * Second degree skin injury; * 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 This is a 3+3 study design. Basically, 3 subjects are recruited at a given intensity level. If major response occurs in ≥2/3 study subjects then the trial will stop at this intensity level. If ≤ 3 subjects shows major response, 3 more subjects are recruited to further test safety at the same intensity level; if no major response occurs (i.e. major response ≤ 1/6), the intensity will be escalated to next higher level; if major response occurs ≥ 2/6 subjects, then the trial will terminate at this intensity level. The sequence for intensity escalation is sham \> 1 W/cm2 \> 2 W/cm2 \> 4W/cm2 \> 6W/cm2 \> 8W/cm2.

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

• Cortical Excitability - Aim 2 of the study

  Cortical excitability is measured by Motor evoked potential(MEP) amplitude using Transcranial Magnetic Stimulation. Mean changes on MEP ( Pre- Post- Ultrasonic Stimulation on the same day) is compared across 5 different stimulation frequency groups.

  Immediately after ultrasonic stimulation

Study Arms (1)

Low Intensity Focused Ultrasonic Stimulation

EXPERIMENTAL

There are different combinations of intensity and frequency with LIFUS

Device: Low Intensity Focused Ultrasonic Stimulation; Device: Low Intensity Focused Ultrasonic Stimulation Frequency

Interventions

Low Intensity Focused Ultrasonic Stimulation 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

Low Intensity Focused Ultrasonic Stimulation Frequency 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)

Low Intensity Focused Ultrasonic Stimulation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Duke University: lead
• American Heart Association: collaborator

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 39842609 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wayne Feng

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 23, 2021
• Study Start: October 11, 2021
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: February 27, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)