Ultrasound Stimulation for Stroke
(LIFUS-OPTIMIZE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach called Low-Intensity Focused Ultrasound Stimulation (LIFUS) to help stroke survivors improve motor skills and cortical excitability (how easily brain cells send signals). Researchers aim to determine if varying power levels and timing frequencies of LIFUS affect its effectiveness. The trial compares different ultrasound power levels and timing frequencies to identify the most effective combination. Participants must have experienced their first stroke at least six months ago and have one-sided arm weakness. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new stroke recovery therapies.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have uncontrolled hypertension or certain neuropsychiatric disorders despite medications, you may not be eligible to participate.
What prior data suggests that Low-Intensity Focused Ultrasound Stimulation is safe for stroke patients?
Research has shown that Low-Intensity Focused Ultrasound Stimulation (LIFUS) is safe for humans, particularly stroke patients. One study found that a single session of LIFUS at up to 8 W/cm² was safe and practical for stroke patients, with no serious side effects observed at this level. Another study confirmed that using ultrasound to influence the brain is safe when specific guidelines are followed. These findings suggest that LIFUS is well-tolerated in humans when used according to established safety protocols.12345
Why are researchers excited about this trial?
Researchers are excited about using Low Intensity Focused Ultrasound Stimulation (LIFUS) for stroke recovery because it offers a non-invasive method to potentially enhance brain function. Unlike traditional treatments such as clot-dissolving drugs or surgical interventions, LIFUS targets the brain directly with sound waves, which could help stimulate neural activity and aid recovery. This innovative approach differs from current methods by using specific intensities and pulse frequencies to activate brain regions without the need for surgery or medication, potentially reducing side effects and recovery time.
What evidence suggests that Low-Intensity Focused Ultrasound Stimulation is effective for stroke recovery?
Research has shown that Low-Intensity Focused Ultrasound Stimulation (LIFUS) could be a promising method for stroke recovery. Studies have found LIFUS to be safe and practical for stroke patients at levels up to 8 W/cm². This trial will explore different LIFUS settings, including varying intensities and pulse repetition frequencies. Participants may receive LIFUS at intensities of 8 W/cm², 4 W/cm², or a sham stimulation at 0 W/cm². Additionally, pulse repetition frequencies of 2000 Hz, 1000 Hz, and 500 Hz will be tested. This method might alter brain activity and improve movement skills. LIFUS has been shown to affect nerve activity and protect nerve cells in ischemic stroke cases. Early trials suggested that adjusting the strength and timing of LIFUS might enhance its effectiveness. The ongoing research aims to determine the optimal settings for these factors.13467
Who Is on the Research Team?
Wayne Feng, MD MS
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for stroke survivors experiencing arm weakness or upper extremity impairment. Participants should be able to give informed consent and have had a stroke at least six months prior to the study. They must not have any contraindications to ultrasound therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Low-Intensity Focused Ultrasound Stimulation (LIFUS) at varying intensities and frequencies to optimize parameters for cortical excitability and motor learning skills
Follow-up
Participants are monitored for motor sequence learning and corticospinal excitability immediately after intervention and 1 hour after intervention
What Are the Treatments Tested in This Trial?
Interventions
- Low Intensity Focused Ultrasound Stimulation
Trial Overview
Researchers are testing Low-Intensity Focused Ultrasound Stimulation (LIFUS) on stroke patients to find the most effective settings for improving motor skills and brain activity. They're looking at different power levels (8, 4 W/cm^2 vs sham) and frequencies (500, 1000, 2000 Hz).
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
each participant will receive LIFUS with pulse repetition frequency at 2000 Hz
each participant will receive LIFUS with pulse repetition frequency at 1000 Hz
Participants will receive LIFUS with pulse repetition frequency at 500 Hz
Participant will receive ultrasound stimulation at intensity of 8 W/cm\^2 (estimated intracranial spatial-peak pulse-average intensities, ISPPA).
Participant will receive ultrasound stimulation at intensity of ISPPA of 4 W/cm\^2
Participant will receive ultrasound stimulation at ISPPA- 0 W/cm\^2 or sham stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Citations
Low intensity focused ultrasound stimulation in stroke
Our phase-I safety study suggests that one session of LIFUS up to 8 W/cm2 ISPPA is safe and feasible in stroke patients, and LIFUS at high intensity induces ...
Low intensity focused ultrasound stimulation in stroke
Our phase-I safety study suggests that one session of LIFUS up to 8 W/cm 2 I SPPA is safe and feasible in stroke patients.
3.
fusfoundation.org
fusfoundation.org/posts/focused-ultrasound-and-stroke-results-from-two-recent-clinical-trials/Results from Two Recent Clinical Trials
Recent clinical trials investigated two interesting focused ultrasound approaches for addressing the treatment of stroke.
Low Intensity Focused Ultrasound Stimulation in Stroke ...
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 ...
Progress in Noninvasive Low-Intensity Focused Ultrasound ...
LIFU shows neuromodulatory and neuroprotective effects on ischemic stroke (IS), and some recent studies have investigated the effects of LIFU on ...
Safety of Clinical Ultrasound Neuromodulation - PMC
For clinical applications, TPS has been shown to be safe, when sticking to our published patient protocols and exclusion/inclusion criteria, such as no signs of ...
Low-intensity focused ultrasound stimulation promotes ...
Low-intensity focused ultrasound stimulation (LIFUS) has been developed to enhance neurological repair and remodelling of ischaemic stroke in ...
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