StrokeLIFUNCT05016531
Optimizing Parameters of Low-Intensity Focused Ultrasound for Cortical Modulation in Stroke Patients
A study testing Low Intensity Focused Ultrasonic Stimulation and Low Intensity Focused Ultrasonic Stimulation Frequency in people with Stroke, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Low Intensity Focused Ultrasonic Stimulation and Low Intensity Focused Ultrasonic Stimulation Frequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 17 Apr 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
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.
Read the 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
- Being tested
- Low Intensity Focused Ultrasonic Stimulation, Low Intensity Focused Ultrasonic Stimulation Frequency
- Keywords
- low intensity focused ultrasound, stroke, brain stimulation, ultrasonic stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity Focused Ultrasonic StimulationDevice
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 FrequencyDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Focused Ultrasonic Stimulation | Experimental | There are different combinations of intensity and frequency with LIFUS Receives: Device: Low Intensity Focused Ultrasonic Stimulation; Device: Low Intensity Focused Ultrasonic Stimulation Frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcomes as Measured by the Number of Participants With a "Major Response"
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.
Measured: At any point during or immediately following intervention on day of LIFUS application
Secondary outcomes (2)
Cortical Excitability as Measured by the Number of Participants Who Improved by ≥ 20% on Motor Evoked Potential (MEP) Amplitude
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.
Measured: Immediately after ultrasonic stimulation
Motor Sequence Learning (MSL) as Measured by the Number of Participants Who Improved by ≥ 20% on a MSL Task
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.
Measured: Immediately after ultrasonic stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start11 Oct 2021
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Wayne Feng, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016531
- Sponsor's protocol ID
- Pro00106556
- Acronym
- LIFU
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2021
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: we will follow the American Heart Association/American Stroke Association data sharing policy per grant requirement
Publications
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.
PubMed 39842609