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Healthy VolunteersNCT07508722

Transcranial Ultrasonic Neuromodulation of Primary Visual Cortex and Primary Auditory Cortex in Humans

A study testing Transcranial Focused Ultrasound Stimulation, Electroencephalography and Magnetic Resonance Imaging in people with Healthy Volunteers and no Condition, Basic Science, run by Massachusetts Institute of Technology at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

There are a number of disorders of the brain that have limited treatment options, such as chronic pain, addiction, and major depression. A new technology has emerged in the last decade known as transcranial focused ultrasound, which can deliver focused acoustic signals through the skull to modulate brain activity over… Read more about this study

Who is it for?
Ages 21 to 55 yearsHealthy volunteers can take part
What is being tested?
Transcranial Focused Ultrasound Stimulation, Electroencephalography and Magnetic Resonance Imaging
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 1 Jun 2027
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 21 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

The inclusion criteria for this study are as follows:

  1. Healthy male and female adults aged 21-55.
  2. No contraindications to magnetic resonance imaging (MRI) scans, such as claustrophobia.

The exclusion criteria for this study are as follows:

  1. History of major medical, neurological (including peripheral nerve disease) or psychiatric illness.
  2. History of vsacular conditions, predisposition to hemorrhage, or blood thinner medications
  3. History of head trauma with loss of consciousness.
  4. Use of sedatives, analgesics and agents that affect brain function.
  5. Contraindications for exposure to the high magnetic field of MRI imaging
  6. History of skin irritation from acoustic coupling materials such as a water-based gel and polyvinyl alcohol (PVA; a common household plastic bag material).
  7. Vulnerable subpopulations (pregnant women, children, institutionalized individuals).
  8. Use of excessive alcohol (e.g., no more than one can of beer or glass of wine) or strenuous exercise (e.g., no more than daily routine) on the day of the visit

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel K Freeman, Ph.D. contact

617-877-7145

Daniel.Freeman@ll.mit.edu

United States1 site
  • Massachusetts Institute of Technology - McGovern Institute for Brain Research

    Cambridge, Massachusetts, 02139

    Daniel K Freeman, Ph.D., 617-877-7145, Daniel.Freeman@ll.mit.edu

Other trials in United States

About this study

There are a number of disorders of the brain that have limited treatment options, such as chronic pain, addiction, and major depression. A new technology has emerged in the last decade known as transcranial focused ultrasound, which can deliver focused acoustic signals through the skull to modulate brain activity over a small region, including structures deep in the brain. This has resulted in many ongoing clinical trials for various disorders, but there is still a lack of understanding of the optimal sonication parameters for increasing versus decreasing brain activity. The investigators aim to address this open question by sonicating the primary visual cortex and primary auditory cortex in human with a range of sonication parameters. These brain structures were chosen to target because they are expected to elicit perceptual responses in the subject (i.e., the subject will report visual and auditory perception during sonication), allowing the experimenters to infer directly the extent to which neural signals can propagate through the visual and auditory systems in a way that is sufficient to produce conscious perception. Such findings have applications not only in clinical treatments, but also in the fundamental science of the neural basis of sensory perception. Previous work has shown that sonicating the visual cortex in humans can elicit visual perception, but the ultrasonic system in prior work did not have the focusing capabilities that will be employed in this study. At the end of this study, the investigators will have determined the optimal sonication parameters that can elicit neural responses over a small volume over sensory cortex, which can be inferred from visual percepts being localized in space (e.g., a bright spot as opposed to a diffuse light), and auditory percepts that sound like pure tones rather than a broad set of frequencies (e.g., sounding like white noise or static).

Read the detailed description

This study will evaluate the effects of low-intensity transcranial focused ultrasound (tFUS) on brain activity in healthy adult volunteers. Transcranial ultrasound is a non-invasive technique that delivers acoustic energy through the skull to a small, targeted region of the brain. Unlike other forms of non-invasive brain stimulation, ultrasound can reach deep and superficial brain structures with millimeter-scale precision.

Transcranial ultrasound is currently being explored as a potential treatment for neurological and psychiatric conditions, including chronic pain, addiction, and depression. However, the optimal stimulation parameters for increasing versus decreasing brain activity in humans are not yet well established. The purpose of this study is to determine which ultrasound pulse parameters produce measurable excitation or suppression of brain activity in the human cortex.

The study will focus on two brain regions: the primary visual cortex and the primary auditory cortex. These regions were selected because stimulation of these areas may produce perceptual experiences, such as seeing flashes of light or hearing tones. These perceptual reports, together with brain recordings, allow researchers to directly assess how ultrasound affects neural activity.

Participants will complete three visits.

During Visit 1, participants will undergo informed consent, baseline testing of visual or auditory function, and magnetic resonance imaging (MRI). MRI scans will be used to identify each participant's individual brain anatomy and precisely localize the stimulation target.

During Visit 2, participants will undergo ultrasound stimulation while brain activity is recorded using electroencephalography (EEG). EEG is a non-invasive method that measures electrical signals from the scalp. Baseline brain responses to visual or auditory stimuli will be recorded before stimulation. Ultrasound will then be delivered in brief bursts while EEG continues to record brain activity. Participants may be asked to report any sensations experienced during stimulation. After stimulation, additional EEG recordings and behavioral tests will be performed to evaluate short-term effects.

Three different ultrasound pulse durations will be tested in randomized order. Each stimulation condition will consist of short bursts separated by rest periods. Total stimulation time will be limited, and rest intervals will be included between conditions.

During Visit 3, which will occur at least one week later, participants will repeat behavioral testing and undergo a follow-up structural MRI scan to confirm that no structural changes occurred.

The ultrasound intensities used in this study are below established U.S. Food and Drug Administration (FDA) safety limits for diagnostic ultrasound. The spatial peak pulse average intensity (Isppa) and spatial peak temporal average intensity (Ispta) will be maintained below FDA exposure limits, even before accounting for attenuation of the signal by the skull. Mechanical index (MI) values will also remain below recommended safety thresholds. Based on prior human studies involving thousands of participants, the risk of serious adverse effects is considered very low.

Potential risks include temporary scalp discomfort, mild skin irritation from ultrasound gel, or transient sensory effects such as light flashes or sounds. Although seizures have not been reported in human studies using these parameters, ultrasound does modulate brain activity, and a theoretical risk exists similar to other non-invasive brain stimulation methods. Participants will be monitored throughout all procedures.

There is no direct medical benefit to participants. However, the findings from this study may help guide the development of ultrasound-based treatments for neurological and psychiatric disorders and improve understanding of how targeted brain stimulation affects sensory perception.

Data collected will include MRI images, EEG recordings, behavioral performance measures, and participant-reported experiences. All data will be coded and stored securely in accordance with institutional policies.

Being tested
Transcranial Focused Ultrasound Stimulation, Electroencephalography, Magnetic Resonance Imaging
Keywords
Transcranial Focused Ultrasound, Non-invasive Brain Stimulation, Ultrasound Neuromodulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Focused Ultrasound StimulationDevice

    Also called Low-Intensity Focused Ultrasound (LIFU)

    Low-intensity transcranial focused ultrasound delivered to either the primary visual cortex or primary auditory cortex using a research ultrasound system. Three pulse durations are tested in randomized order during a single study session while brain activity and behavioral responses are measured.

  • ElectroencephalographyDevice

    Also called EEG

    Noninvasive recording of brain electrical activity from scalp electrodes before, during, and after ultrasound stimulation.

  • Magnetic Resonance ImagingDevice

    Also called MRI

    Structural and functional magnetic resonance imaging used for anatomical localization of stimulation targets and follow-up safety assessment.

Study groups in NCT07508722
Study groupRoleWhat they receive
Experimental: Transcranial Focused Ultrasound StimulationExperimentalParticipants 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.
Receives: Device: Transcranial Focused Ultrasound Stimulation; Device: Electroencephalography; Device: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in sensory-evoked cortical response measured by electroencephalography

    Change in peak-to-peak amplitude (µV) of sensory-evoked potentials recorded from scalp electroencephalography (EEG) over the targeted cortical region (visual or auditory cortex, depending on stimulation condition) during and after transcranial focused ultrasound stimulation, relative to baseline (pre-stimulation).

    Measured: Measured during Visit 2 (baseline, during stimulation, immediately post-stimulation, and 15-20 minutes post-stimulation)

  2. Change in visual detection threshold

    Change in visual sensitivity thresholds measured using the visual field analyzer, quantified as detection threshold before and after transcranial focused ultrasound stimulation.

    Measured: Baseline (Visit 1); pre-stimulation (Visit 2); immediately after stimulation (Visit 2); and 1 week after stimulation (Visit 3)

  3. Change in auditory tone detection threshold

    Change in auditory detection thresholds measured using commercial audiometry system (e.g., WAHTS Hearing), quantified as minimum detectable sound level (dB HL) across frequencies (250 Hz-8 kHz) before and after transcranial focused ultrasound stimulation.

    Measured: Baseline (Visit 1); pre-stimulation (Visit 2); immediately after stimulation (Visit 2); and 1 week after stimulation (Visit 3)

Secondary outcomes (2)
  1. Participant-reported perceptual intensity measured by numeric rating scale during transcranial focused ultrasound stimulation

    Participant-reported sensory percepts occurring during transcranial focused ultrasound stimulation (e.g., visual flashes or auditory tones), quantified using a numeric rating scale (0-10), where 0 indicates no percept and 10 indicates maximum perceived intensity. Presence or absence of percepts will also be recorded.

    Measured: During each stimulation block (each approximately 6-7 minutes; up to 20 minutes total) at Visit 2

  2. Number of participants with new structural brain abnormalities on MRI following transcranial focused ultrasound stimulation

    Structural magnetic resonance imaging (MRI) (T1-weighted and susceptibility-weighted imaging) will be evaluated by a qualified radiologist to identify any new or worsened structural abnormalities in the sonicated brain region compared to baseline imaging. The outcome will be reported as the number of participants with identified abnormalities.

    Measured: 1 week after stimulation (Visit 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion18 Nov 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07508722
Sponsor's protocol ID
2507001708
Other IDs
TI25-5201
Status last verified
Jun 2026
First submitted
27 Feb 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because this is a small, exploratory study in healthy volunteers, and there are no plans for public release of de-identified participant-level data. Results will be reported in aggregate form in scientific publications.

Publications

  • Freeman DK, Odegaard B, Yoo SS, Michel M. Transcranial focused ultrasound for identifying the neural substrate of conscious perception. Neurosci Biobehav Rev. 2026 Jan;180:106485. doi: 10.1016/j.neubiorev.2025.106485. Epub 2025 Nov 19.

    PubMed 41270981

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Focused Ultrasound Stimulation, Electroencephalography and Magnetic Resonance Imaging in people with Healthy Volunteers and no Condition, Basic Science, run by Massachusetts Institute of Technology 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?

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: opening soon, as of the sponsor's last update on 29 Jun 2026. 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. 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 Daniel K Freeman, Ph.D. (617-877-7145, Daniel.Freeman@ll.mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in sensory-evoked cortical response measured by electroencephalography (time frame: Measured during Visit 2 (baseline, during stimulation, immediately post-stimulation, and 15-20 minutes post-stimulation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07508722, which also lists 1 linked publication.

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 29 Jun 2026.

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