Optimizing Parameters of Low-Intensity Focused Ultrasound for Cortical Modulation in Stroke Patients (LIFU)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Low Intensity Focused Ultrasonic Stimulation
There are different combinations of intensity and frequency with LIFUS
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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)
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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Safety Outcomes as Measured by the Number of Participants With a "Major Response"
Time Frame: At any point during or immediately following intervention on day of LIFUS application
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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.
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At any point during or immediately following intervention on day of LIFUS application
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cortical Excitability as Measured by the Number of Participants Who Improved by ≥ 20% on Motor Evoked Potential (MEP) Amplitude
Time Frame: Immediately after ultrasonic stimulation
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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.
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Immediately after ultrasonic stimulation
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Motor Sequence Learning (MSL) as Measured by the Number of Participants Who Improved by ≥ 20% on a MSL Task
Time Frame: Immediately after ultrasonic stimulation
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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.
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Immediately after ultrasonic stimulation
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wayne Feng, Duke Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00106556
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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