Low Intensity Focused Ultrasound for Neural Mapping
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the brain responds to low-intensity focused ultrasound (LIFU), a non-invasive technique using sound waves to stimulate the brain. The researchers aim to understand brain circuit connectivity in real-time by observing reactions in patients with implanted electrodes. The trial targets adults hospitalized for epilepsy or neuropsychiatric conditions who have undergone or will undergo electrode implantation surgery. Participants must be stable in their medical condition and able to follow instructions in English. This research could help map brain activity and improve future treatments for neurological conditions. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance neurological treatments.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this method is safe for neural mapping?
Research has shown that low-intensity focused ultrasound (LIFU) is generally safe and well-tolerated. Studies have found that LIFU provides a safe and non-invasive method to influence brain activity. In one safety study, even at high intensity, LIFU proved safe for patients recovering from strokes. Another study confirmed that the intensity of LIFU used remained within the FDA's safety limits, posing a "non-significant risk."
Participants in various studies reported very few side effects, and the technology is considered safe with precise targeting abilities. Overall, evidence suggests that LIFU is safe for people, with very few negative effects reported.12345Why are researchers excited about this trial?
Low Intensity Focused Ultrasound (LIFU) is unique because it offers a non-invasive approach to neural mapping, which could transform how we understand and treat neurological conditions. Unlike traditional methods that might require surgery or external devices, LIFU uses sound waves to precisely target and map brain activity without the need for incisions. Researchers are excited about this treatment because it has the potential to provide a safer, more accurate way to explore brain functions, leading to better diagnosis and treatment plans for patients.
What evidence suggests that low intensity focused ultrasound is effective for neural mapping?
Research has shown that Low Intensity Focused Ultrasound (LIFU), which participants in this trial will receive, can safely alter brain function. Studies suggest it might help treat conditions like depression and chronic pain by targeting specific brain areas. For example, one study found that LIFU reduced a brain signal related to pain by 38.1%. This indicates that LIFU can affect brain function without surgery. Although more research is needed, these early results suggest it could effectively change brain activity.16789
Are You a Good Fit for This Trial?
This trial is for adults aged 21-75 who are already having electrodes placed in their brain to monitor epilepsy or neuropsychiatric conditions. Participants must be medically stable, able to understand instructions in English, and able to give consent. People with certain implants, scalp issues, pregnancy, or serious health problems can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
LIFU Experiment
Participants receive brief, non-therapeutic transcranial low-intensity focused ultrasound (LIFU) pulses while undergoing intracranial electrophysiological monitoring
Follow-up
Participants are monitored for safety and effectiveness after LIFU exposure
What Are the Treatments Tested in This Trial?
Interventions
- Low Intensity Focused Ultrasound
Trial Overview
The study tests how the brain responds right away to brief pulses of low-intensity focused ultrasound (LIFU), using implanted electrodes to record brain activity. It involves people already undergoing electrode monitoring as part of their care.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Citations
A Comprehensive Review of Low-Intensity Focused ... - PMC
In this study, we provide a review of the most recent LIFU literature covering three key domains: 1) the history of focused ultrasound ...
Low intensity focused ultrasound
Low intensity pulsed focused ultrasound (LIFU) applies non-invasive acoustic energy to safely modulate neural activity in translational models and non-human ...
Low-intensity ultrasound neuromodulation: An overview of ...
There is an emerging need for noninvasive neuromodulation techniques to improve patient outcomes while minimizing adverse events and morbidity.
Motor and Non-Motor Effects of Low-Intensity Focused ...
This study investigates the motor and non-motor effects of Low-Intensity Focused Ultrasound (LIFU) as a non-invasive neuromodulation technique in patients ...
Progress in Noninvasive Low-Intensity Focused Ultrasound ...
This review discusses the recent and ongoing developments of low-intensity focused ultrasound for neurological regulation.
The efficacy and safety of low-intensity focused ultrasound ...
This study aims to bridge this gap by investigating EEG-based changes in neural dynamics and connectivity associated with LIFUP, thereby ...
A retrospective qualitative report of symptoms and safety ...
We provide an evaluation of the safety of LIFU for human neuromodulation through participant report and neurological assessment with a comparison of ...
Low-Intensity Focused Ultrasound Neuromodulation of the ...
Focused ultrasound itself is a safe, incisionless technology with high spatial resolution and depth penetration that has been shown to stimulate and inhibit ...
The efficacy and safety of low-intensity focused ultrasound ...
Recent randomized controlled trials (RCTs) in patients with prolonged disorders of consciousness (pDoC) have yielded limited success.
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