HealthyNCT03192436
Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound
A study testing Ultrasound in people with Healthy, run by Carnegie Mellon University at 1 site in United States.
Trial summary
Neuromodulation is a fast growing field that offers a wide range of applications for both understanding and treating the brain. Future research for non-invasive neuromodulation will need to elucidate the optimal frequency, duration, and intensity of stimulation for a variety of technologies and diseases. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy volunteers.
- Age 18-64.
- Willing and able to provide written consent.
- Able to communicate in the English language.
Who cannot join
- Subjects having any of the following conditions will be excluded from this study:
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Biomedical Engineering, Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
Joshua Kosnoff, jkosnoff@andrew.cmu.edu
Bin He, PhD
About this study
Neuromodulation is a fast growing field that offers a wide range of applications for both understanding and treating the brain. Future research for non-invasive neuromodulation will need to elucidate the optimal frequency, duration, and intensity of stimulation for a variety of technologies and diseases. Closed loop stimulation is thus a promising research area that allows for responsive stimulation and real time symptom management. Our project is proposed to develop and test a novel noninvasive neuromodulation integrating transcranial focused ultrasound stimulation (tFUS) with electrophysiological source imaging (ESI-tFUS) to allow evidence-based neuromodulation for brain research and the management of brain conditions. Despite the recent developments and attention surrounding tFUS, relatively little is known about the mechanisms and optimal parameters of this stimulation technology. The addition of ESI neuroimaging, aimed at providing biomarkers to assess the effects of tFUS neuromodulation, could provide crucial necessary information regarding the neural response to the applied stimulation in real-time. In order for tFUS to be further developed and transformed into a robust neuromodulation technology, an integrated electrophysiological source-imaging-guided tFUS system to allow for individualized and responsive stimulation is needed.
The purpose of this study is to develop and evaluate the proposed ESI-tFUS in human subjects using motor and somatosensory paradigms.
Read the detailed description
In this protocol, the following hypothesis will be tested; the electroencephalography (EEG) and transcranial focused ultrasound (tFUS) will be used to quantify and optimize stimulation effects. We will test the hypothesis that tFUS can induce regional brain activity and use EEG to localize and image the brain electrical activity as induced by TFUS stimulation. Subjects will be recruited for MRI scan and then undergo motor and/or sensory tasks, and during these tasks, subjects will receive tFUS and concurrently be monitored by EEG. This tFUS-EEG study is aimed at exploring effects of tFUS and the use of EEG in providing electrophysiological responses to brain activation following tFUS stimulation.
- Conditions
- Healthy
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Low-intensity (Ispta < 720 mW/cm2, Isppa < 190 W/cm2) transcranial focused ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Real Ultrasound | Active comparator | The subjects will receive real ultrasound intervention. Receives: Device: Ultrasound |
| Sham Ultrasound | Sham comparator | The subjects will receive sham ultrasound intervention. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closed-loop control of ultrasound neuromodulation as assessed by EEG source imaging
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.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Sep 2018
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bin He, University of Minnesota
- Investigators
- Bin He, Ph.D., Principal investigator, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192436
- Sponsor's protocol ID
- STUDY2017_00000426
- Status last verified
- Nov 2025
- First submitted
- 13 Jun 2017
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Source Imaging Guided Transcranial Focused Ultrasound
- ClinicalTrials.gov ID
- NCT03192436
- Acronym / sponsor ID
- STUDY2017_00000426
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuromodulation is a fast growing field that offers a wide range of applications for both understanding and treating the brain. Future research for non-invasive neuromodulation will need to elucidate the optimal frequency, duration, and intensity of stimulation for a variety of technologies and diseases. Closed loop stimulation is thus a promising research area that allows for responsive stimulation and real time symptom management. Our project is proposed to develop and test a novel noninvasive neuromodulation integrating transcranial focused ultrasound stimulation (tFUS) with electrophysiological source imaging (ESI-tFUS) to allow evidence-based neuromodulation for brain research and the management of brain conditions. Despite the recent developments and attention surrounding tFUS, relatively little is known about the mechanisms and optimal parameters of this stimulation technology. The addition of ESI neuroimaging, aimed at providing biomarkers to assess the effects of tFUS neuromodulation, could provide crucial necessary information regarding the neural response to the applied stimulation in real-time. In order for tFUS to be further developed and transformed into a robust neuromodulation technology, an integrated electrophysiological source-imaging-guided tFUS system to allow for individualized and responsive stimulation is needed.
The purpose of this study is to develop and evaluate the proposed ESI-tFUS in human subjects using motor and somatosensory paradigms.
Detailed description
In this protocol, the following hypothesis will be tested; the electroencephalography (EEG) and transcranial focused ultrasound (tFUS) will be used to quantify and optimize stimulation effects. We will test the hypothesis that tFUS can induce regional brain activity and use EEG to localize and image the brain electrical activity as induced by TFUS stimulation. Subjects will be recruited for MRI scan and then undergo motor and/or sensory tasks, and during these tasks, subjects will receive tFUS and concurrently be monitored by EEG. This tFUS-EEG study is aimed at exploring effects of tFUS and the use of EEG in providing electrophysiological responses to brain activation following tFUS stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Ultrasound | Active comparator | Device: UltrasoundThe subjects will receive real ultrasound intervention. |
| Sham Ultrasound | Sham comparator | Device: UltrasoundThe subjects will receive sham ultrasound intervention. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Apparently healthy volunteers.
- Age 18-64.
- Willing and able to provide written consent.
- Able to communicate in the English language.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundLow-intensity (Ispta < 720 mW/cm2, Isppa < 190 W/cm2) transcranial focused ultrasound | Device | Real Ultrasound, Sham Ultrasound |
Primary outcome
Closed-loop control of ultrasound neuromodulation as assessed by EEG source imaging
Time frame: up 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bin He, Ph.D. principal investigator
Carnegie Mellon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Healthy, run by Carnegie Mellon University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Kosnoff (310-343-8702, jkosnoff@andrew.cmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closed-loop control of ultrasound neuromodulation as assessed by EEG source imaging (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.