Stroke
Conditions
Keywords
low intensity focused ultrasound, stroke, brain stimulation, ultrasonic stimulation
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.
Interventions
DEVICELow 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)
DEVICELow 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)
Sponsors
Duke University
American Heart Association
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcomes as Measured by the Number of Participants With a "Major Response" | 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
| Measure | Time frame | Description |
|---|---|---|
| Cortical Excitability as Measured by the Number of Participants Who Improved by ≥ 20% on Motor Evoked Potential (MEP) Amplitude | Immediately after ultrasonic stimulation | 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. |
| Motor Sequence Learning (MSL) as Measured by the Number of Participants Who Improved by ≥ 20% on a MSL Task | Immediately after ultrasonic stimulation | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWayne Feng
Duke Health
Participant flow
Pre-assignment details
Unable to complete Aim 2. No Aim 2 participants were enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
None listed