Transcranial Focused Ultrasound for Brain Research

This study is testing a new way to understand and treat the brain using a device called transcranial focused ultrasound (tFUS). Researchers want to see if tFUS can safely change brain activity and if they can measure these changes using electroencephalography (EEG), which records brain waves. They are looking for 80 healthy volunteers, aged 18 to 64, who can speak English. The main goal is to see if tFUS can be controlled in real-time to affect brain activity, as measured by EEG, over a period of up to two years. This research aims to develop better ways to study and manage brain conditions in the future.

Study design
This is an interventional study planning to enroll 80 healthy volunteers. It is not specified if it is randomized or blinded.
What's involved
You would undergo an MRI scan, perform motor and/or sensory tasks, and receive tFUS while your brain activity is monitored by EEG.
Compensation
Not stated in the trial record.
Follow-up
Your brain activity will be assessed for up to two years after the intervention.

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NCT03192436

Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound

Recruiting
NAAges 18–64InterventionalBasic science
Carnegie Mellon University
~80 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:Ultrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Closed-loop control of ultrasound neuromodulation as assessed by EEG source imaging
Measured over up to 2 years
Healthy
1 sites across 1 states
Pennsylvania1
  • Bin He, Ph.D. · PRINCIPAL_INVESTIGATOR · Carnegie Mellon University

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Eligibility criteria

Inclusion

Apparently healthy volunteers.
Age 18-64.
Willing and able to provide written consent.
Able to communicate in the English language.

Exclusion

Evidence of a current significant medical illness or psychiatric or central or peripheral neurologic disorder
History of loss of consciousness of more than ten minutes in the past year or loss of consciousness in a lifetime that required rehabilitation services
Personal or family history of seizure
Any history of stroke/transient ischemic attack (TIA)
Taking any medications that are known to decrease the threshold for seizure
Pregnancy
Affirmative answers to one or more questions of the provided attached safety questionnaires. These are not absolute contraindications to this study but the risk/benefit ratio will be carefully considered by the PI
Failure to follow laboratory or study procedures
  • Closed-loop control of ultrasound neuromodulation as assessed by EEG source imagingup to 2 years

    The primary study outcome is a closed-loop control algorithm to control the parameters in administrating the tFUS. The outcome data of the study will include the MRI data, EEG data, tFUS location and timing data, perceptual (subject reported) effects of tFUS and/or pins, and any reported adverse events. Analysis of the EEG data will be conducted using EEG analysis software, and the customized software to be developed at the PI's lab. The EEG data will also be correlated with tFUS application. The output of our data analysis process will be in the form of quantitative spatial estimation of tFUS activation in the brain using EEG source reconstruction.