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

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Massachusetts Institute of Technology
Study ID
NCT07508722
Status
Not Yet Recruiting

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Conditions

  • Healthy Volunteers
  • no Condition, Basic Science

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Transcranial Focused Ultrasound Stimulation — DEVICE
    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.
  • Electroencephalography — DEVICE
    Noninvasive recording of brain electrical activity from scalp electrodes before, during, and after ultrasound stimulation.
  • Magnetic Resonance Imaging — DEVICE
    Structural and functional magnetic resonance imaging used for anatomical localization of stimulation targets and follow-up safety assessment.

Study Details

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).

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Nov 18, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Experimental: Transcranial Focused Ultrasound Stimulation
    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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Institute of Technology - McGovern Institute for Brain ResearchCambridgeMassachusetts02139
Daniel K Freeman, Ph.D.
[email protected]
617-877-7145

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By research site
Massachusetts Institute of Technology - McGovern Institute for Brain Research· Cambridge, MA

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