Transcranial Focused Ultrasound for Brain Modulation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to potentially treat brain disorders such as chronic pain, addiction, and depression using focused sound waves. These sound waves, known as transcranial focused ultrasound, aim to alter brain activity by targeting specific brain areas. Researchers are studying this technique, also called Transcranial Ultrasonic Neuromodulation, to determine the optimal settings for these sound waves by observing their effects on sight and hearing. The trial seeks healthy adults who can safely undergo an MRI scan and have no history of major health issues or use of brain-affecting medications.
As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to innovative treatments for brain disorders.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking sedatives, pain relievers, and any drugs that affect brain function to participate in this trial.
What prior data suggests that transcranial focused ultrasound is safe for brain modulation?
A previous study found transcranial focused ultrasound (tFUS) to be safe and well-tolerated. Research shows that tFUS can safely stimulate the brain without surgery. Trials with stroke patients reported only minor and short-lived side effects, indicating temporary and non-harmful discomfort. Other studies indicate that tFUS can accurately target small brain areas, making it a promising option for individuals with brain disorders. Overall, the treatment has demonstrated safety in both humans and animals, with minimal risks.12345
Why are researchers excited about this trial?
Transcranial Ultrasonic Neuromodulation is unique because it uses focused ultrasound waves to non-invasively stimulate specific areas of the brain, such as the primary visual or auditory cortex. Unlike traditional treatments like medication or invasive brain stimulation, this technique offers a new way to modulate brain activity without surgery or drugs. Researchers are excited about this approach because it allows precise targeting and modulation of brain regions, potentially leading to more effective and personalized treatments for neurological conditions.
What evidence suggests that transcranial focused ultrasound is effective for brain modulation?
Research has shown that transcranial focused ultrasound (tFUS), the treatment under study in this trial, is a promising method for influencing brain activity. Studies have found that it can target specific brain areas without surgery. For conditions like depression and chronic pain, tFUS has demonstrated potential by affecting both surface and deeper brain regions. Some studies indicate that tFUS can alter perception, suggesting it activates the appropriate brain regions. Although this technology remains new, early results are promising for its ability to precisely and safely modify brain activity.23678
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 21-55 with no major medical, neurological, or psychiatric conditions. Participants must not have issues with MRI scans, history of head trauma with loss of consciousness, blood vessel problems, skin reactions to gels/plastics used in the study, or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Testing and MRI
Informed consent, baseline visual or auditory testing, and MRI for target localization
Ultrasound Stimulation and EEG Recording
Ultrasound stimulation with EEG recording, including baseline and post-stimulation assessments
Follow-up and Structural MRI
Repeat behavioral testing and follow-up structural MRI to confirm no structural changes
What Are the Treatments Tested in This Trial?
Interventions
- Transcranial Ultrasonic Neuromodulation
Trial Overview
Researchers are testing how focused ultrasound can safely and precisely stimulate specific brain areas related to vision and hearing. They use EEG and MRI to monitor effects while adjusting ultrasound settings to see what causes visual or auditory sensations.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants complete three visits. Visit 1 includes informed consent, baseline visual or auditory testing, and magnetic resonance imaging (MRI) for target localization. Visit 2 includes electroencephalography (EEG) recording and low-intensity transcranial focused ultrasound (tFUS) delivered to either primary visual cortex or primary auditory cortex (each participant receives one target only). Three ultrasound pulse durations are delivered in randomized order while EEG and behavioral responses are measured before, during, and after stimulation. Visit 3 (≥1 week later) includes repeat behavioral testing and a follow-up structural MRI.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts Institute of Technology
Lead Sponsor
MIT Lincoln Laboratory
Collaborator
Citations
Transcranial ultrasound stimulation in neuromodulation - PMC
Transcranial ultrasound stimulation (TUS) is a non-invasive neuromodulation technique with promising clinical potential.
Transcranial ultrasound neuromodulation: A registry-based ...
Transcranial ultrasound stimulation (TUS) enables non-invasive neuromodulation of cortical and subcortical brain regions.
Transcranial focused ultrasound in the human brain: Neuron
These procedures, known as magnetic resonance-guided focused ultrasound (MRgFUS), have high spatial resolution, in the order of 1–2 mm, afforded ...
Transcranial Focused Ultrasound Neuromodulation - PMC - NIH
This review synthesizes animal and human research outcomes and offers an integrated description of the excitatory and inhibitory effects of tFUS.
Neuromodulation with transcranial focused ultrasound in
Our ability to control or influence neural activity in the human brain has rested on methods that are either invasive or limited by a broad radius of action.
Safety of Clinical Ultrasound Neuromodulation - PMC - NIH
Transcranial ultrasound holds much potential as a safe, non-invasive modality for navigated neuromodulation, with low-intensity focused ultrasound (FUS) and ...
Transcranial Ultrasonic Neuromodulation of Primary Visual ...
The purpose of this study is to determine which ultrasound pulse parameters produce measurable excitation or suppression of brain activity in the human cortex.
Transcranial focused ultrasound induces source ...
The effects of transcranial focused ultrasound (tFUS) on the human brain are poorly understood. Currently, the field is at odds with whether ...
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