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NCT Number: NCT05303428

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

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.

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Key information

Conditions

Cognitive Change

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
  • History of head injury resulting in loss of consciousness for >10 minutes.
  • History of alcohol or drug dependence (through self-report).

Treatment and study plan

Neuromodulation with low-intensity focused ultrasound

Other

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

Primary outcomes

  1. fMRI Signals - Cognition

    Time frame: Participant study duration, approximately 3 weeks.

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

Secondary outcomes

  1. Executive function task performance

    Time frame: Participant study duration, approximately 3 weeks.

    Testing effects of LIFU on altered task performance

Other outcomes

  1. Assess for changes in physiological measures

    Time frame: Participant study duration, approximately 3 weeks.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Florig, MPH

CONTACT

[email protected]

5405262375

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 31, 2022
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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