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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-55
SponsorMassachusetts Institute of Technology

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male and female adults aged 21-55.

No contraindications to magnetic resonance imaging (MRI) scans, such as claustrophobia.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Experimental: Transcranial Focused Ultrasound StimulationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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).

Time frame
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.

Time frame
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.

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

Secondary outcomes

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.

Time frame
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.

Time frame
1 week after stimulation (Visit 3)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Institute of Technology

Lead sponsor

MIT Lincoln Laboratory

Collaborator

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