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Clinical Trials/NCT07508722
NCT07508722Not yet recruitingNot Applicable

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

Massachusetts Institute of Technology1 site in 1 country20 target enrollmentStarted: October 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
20
Locations
1
Primary Endpoint
Change in sensory-evoked cortical response measured by electroencephalography

Study Overview

Brief 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 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).

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
21 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • The inclusion criteria for this study are as follows:
  • Healthy male and female adults aged 21-
  • No contraindications to magnetic resonance imaging (MRI) scans, such as claustrophobia.

Exclusion Criteria

  • for this study are as follows:
  • History of major medical, neurological (including peripheral nerve disease) or psychiatric illness.
  • History of vsacular conditions, predisposition to hemorrhage, or blood thinner medications
  • History of head trauma with loss of consciousness.
  • Use of sedatives, analgesics and agents that affect brain function.
  • Contraindications for exposure to the high magnetic field of MRI imaging
  • History of skin irritation from acoustic coupling materials such as a water-based gel and polyvinyl alcohol (PVA; a common household plastic bag material).
  • Vulnerable subpopulations (pregnant women, children, institutionalized individuals).
  • 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

Arms & Interventions

Experimental: Transcranial Focused Ultrasound Stimulation

Experimental

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.

Intervention: Magnetic Resonance Imaging (Device)

Experimental: Transcranial Focused Ultrasound Stimulation

Experimental

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.

Intervention: Transcranial Focused Ultrasound Stimulation (Device)

Experimental: Transcranial Focused Ultrasound Stimulation

Experimental

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.

Intervention: Electroencephalography (Device)

Outcomes

Primary Outcomes

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)

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).

Change in visual detection threshold

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

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

Change in auditory tone detection threshold

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

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.

Secondary Outcomes

  • Participant-reported perceptual intensity measured by numeric rating scale during transcranial focused ultrasound stimulation(During each stimulation block (each approximately 6-7 minutes; up to 20 minutes total) at Visit 2)
  • Number of participants with new structural brain abnormalities on MRI following transcranial focused ultrasound stimulation(1 week after stimulation (Visit 3))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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