Optimizing Parameters of Low-Intensity Focused Ultrasound for Cortical Modulation in Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Safety Outcomes as Measured by the Number of Participants With a "Major Response"
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Low Intensity Focused Ultrasonic Stimulation
There are different combinations of intensity and frequency with LIFUS
Intervention: Low Intensity Focused Ultrasonic Stimulation (Device)
Low Intensity Focused Ultrasonic Stimulation
There are different combinations of intensity and frequency with LIFUS
Intervention: Low Intensity Focused Ultrasonic Stimulation Frequency (Device)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Cortical Excitability as Measured by the Number of Participants Who Improved by ≥ 20% on Motor Evoked Potential (MEP) Amplitude(Immediately after ultrasonic stimulation)
- Motor Sequence Learning (MSL) as Measured by the Number of Participants Who Improved by ≥ 20% on a MSL Task(Immediately after ultrasonic stimulation)