Study of Low-intensity Focused Ultrasound Effects on Cognitive fMRI Signals

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVirginia Polytechnic Institute and State University

About this trial

Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and cognitive brain signaling using structured tasks. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy volunteers, all ethnicities, who understand and speak English.

Disqualifiers

Claustrophobia (scanning environment may be uncomfortable).

Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.

Contraindications to CT: pregnancy

Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)

Trial design

Design model

Single group

Treatments tested in this trial

  • Neuromodulation with low-intensity focused ultrasound

    Other intervention

    application of LIFU to induce temporary neuromodulation, effects tested with resting state and task based fMRI scanning.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: LIFU, fMRI CognitiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

fMRI Signals - Cognition

Changes in fMRI signals of region of interest during a cognitive task

Time frame
Participant study duration, approximately 3 weeks.

Secondary outcomes

1

Executive function task performance

Testing effects of LIFU on altered task performance

Time frame
Participant study duration, approximately 3 weeks.

Other outcomes

1

Assess for changes in physiological measures

Monitoring for any changes in heartrate, blood pressure, respiratory rate, or galvanic skin response throughout testing

Time frame
Participant study duration, approximately 3 weeks.

Locations

This trial has no locations.

Sponsors and contacts

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