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Olfactory Transcranial Focused Ultrasound

Modulation of Olfactory Valence by Transcranial Focused Ultrasound (tFUS)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07658365
Acronym
O-tFUS
Enrollment
28
Registered
2026-06-22
Start date
2026-10-01
Completion date
2028-04-30
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Olfaction

Keywords

healthy volunteer, electroencephalography (EEG), magnetic resonance imaging (MRI), odors

Brief summary

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.

Interventions

non-invasive brain stimulation using tFUS

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Odor Valence Ratingfrom 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)
Late Positive Potentialfrom 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
Sniff Volumefrom 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
Corrugator Supercilii EMG Activityfrom 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

MeasureTime frameDescription
Odor Intensity Ratingfrom 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)
Odor Avoidance Ratingfrom 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")
Sniff Ratefrom the baseline visit until the third follow-up visit (about 1 month)Breaths per min or per trial window in response to odor exposure

Contacts

CONTACTNicole Cash, Study Coordinator
cashni@musc.edu843-790-3449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026