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NCT Number: NCT07658365

Olfactory Transcranial Focused Ultrasound

This study investigates the causal effects of low-intensity transcranial focused ultrasound (tFUS) on odor valence perception and odor-elicited avoidance behaviors in healthy adults. Participants undergo sham and active tFUS targeting the amygdala (AMYG) and ventral striatal olfactory tubercle (VSOT) in a within-subject, randomized, sham-controlled crossover design. Outcomes include subjective odor ratings and objective neurophysiological and behavioral indices of odor valence processing. This research is exploratory and mechanistic in nature and is not intended to evaluate clinical safety or therapeutic efficacy.

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Key information

Conditions

Healthy Anosmia Nervous System Diseases Neurologic Manifestations Olfaction Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

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

  • Age 18-65 years
  • Healthy adult volunteers
  • Normal olfactory function (Sniffin' Sticks total TDI ≥ 30.75)
  • Ability to provide informed consent
  • English fluency sufficient for task completion

Exclusion criteria

  • MRI or tFUS contraindications (e.g., metal implants, claustrophobia, pregnancy)
  • Sinonasal conditions affecting airflow or smell
  • Current use of medications that alter olfaction
  • Positive urine drug screen

Treatment and study plan

transcranial focused ultrasound (tFUS)

Device

non-invasive brain stimulation using tFUS

Primary outcomes

  1. Odor Valence Rating

    Time frame: from the baseline visit until the third follow-up visit (about 1 month)

    Participant rating of odor pleasantness on a 0-100 mm visual analog scale (e.g., unpleasant → pleasant)

  2. Late Positive Potential

    Time frame: from the baseline visit until the third follow-up visit (about 1 month)

    Mean EEG amplitude (400-800 ms) at centro-parietal sites to olfactory-visual stimuli

  3. Sniff Volume

    Time frame: from the baseline visit until the third follow-up visit (about 1 month)

    Total nasal airflow (in mL) per odor trial, measured via nasal cannula or spirometer

  4. Corrugator Supercilii EMG Activity

    Time frame: from the baseline visit until the third follow-up visit (about 1 month)

    Mean EMG amplitude from facial muscle sensitive to negative affect and aversion

Secondary outcomes

  1. Odor Intensity Rating

    Time frame: from the baseline visit until the third follow-up visit (about 1 month)

    Participant rating of odor intensity on a 0-100 mm visual analog scale (e.g., not at all → extremely)

  2. Odor Avoidance Rating

    Time frame: from the baseline visit until the third follow-up visit (about 1 month)

    Participant rating of their desire to avoid the odor on a 0-100 mm visual analog scale (e.g., "not at all" → "extreme")

  3. Sniff Rate

    Time frame: from the baseline visit until the third follow-up visit (about 1 month)

    Breaths per min or per trial window in response to odor exposure

Study contacts

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

Nicole Cash, Study Coordinator

CONTACT

[email protected]

843-790-3449

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Modulation of Olfactory Valence by Transcranial Focused Ultrasound (tFUS)

Acronym: O-tFUS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

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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