No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for adults who have had a stroke and still have weakness in one arm. Participants will receive treatments using low-intensity ultrasound to see if it helps with their motor skills.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 21 years old.
I have had my first stroke at least 6 months ago.
I have weakness in one arm.
My arm weakness measure is 62 or lower on a specific scale.
I can test motor functions in my affected arm.
You may not be able to join if
I have had strokes on both sides of my brain.
I have another nerve or muscle disorder affecting my arm.
I have a history of serious depression or other mental health issues.
I have been diagnosed with dementia.
My blood pressure is too high despite treatment.
I have factors that are unsafe for MRI or ultrasound.
I am part of another stroke recovery study.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this research study is to optimize the parameter of Low-Intensity Focused Ultrasound Stimulation (LIFUS) that is most effective in changing cortical excitability and motor learning skills in patients who suffered a stroke. The researchers hope to answer two questions.
* with increasing power, would LIFUS be more effective?
* with the same power, what LIFUS timing is the best
For Aim …
The goal of this research study is to optimize the parameter of Low-Intensity Focused Ultrasound Stimulation (LIFUS) that is most effective in changing cortical excitability and motor learning skills in patients who suffered a stroke. The researchers hope to answer two questions.
* with increasing power, would LIFUS be more effective?
* with the same power, what LIFUS timing is the best
For Aim 1, the study will compare 8, 4 W/cm\^2 to a zero(sham) stimulation to see if higher power is the better.
For Aim 2, the study will compare 500 vs 1000 vs 2000 Hz "timing" to see which one is better.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* age \>=21 years old of any gender or race
* First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from the stroke onset of symptoms
* Unilateral arm weakness measured by the Fugl-Meyer Upper-Extremity Scale ≤ 62/64
* Inducible resting motor thresh…
Inclusion Criteria:
* age \>=21 years old of any gender or race
* First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from the stroke onset of symptoms
* Unilateral arm weakness measured by the Fugl-Meyer Upper-Extremity Scale ≤ 62/64
* Inducible resting motor threshold and testing motor threshold recorded from an affected upper extremity muscle
Exclusion Criteria:
* Bilateral strokes (infarcts and/or hematoma)
* Other co-existent neuromuscular disorders affecting upper extremity motor impairment
* History of medically uncontrolled depression or other neuropsychiatric disorders despite medications either before or after a stroke that may affect the subject's ability to participate in the study
* History of confirmed dementia or taking dementia drugs
* Uncontrolled hypertension despite medical treatment(s) at the time of enrollment, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and enrolled later)
* Presence of any MRI/TMS/LIFUS risk factors
* Concurrent enrollment in another interventional stroke recovery study
* Concerns that the subject cannot comply with study procedures and visits
* Pregnant
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