Ultrasound Stimulation for Stroke

(LIFUS-OPTIMIZE 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.

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.

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

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.

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