Olfactory Transcranial Focused Ultrasound (O-tFUS)

June 15, 2026 updated by: Bernadette Cortese, Medical University of South Carolina

Modulation of Olfactory Valence by Transcranial Focused Ultrasound (tFUS)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nicole Cash, Study Coordinator
  • Phone Number: 843-790-3449
  • Email: cashni@musc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active tFUS targeting the Amygdala (AMYG)
Active tFUS of the bilateral Amygdala randomized at one of the three stimulation visits
Device: transcranial focused ultrasound (tFUS)
non-invasive brain stimulation using tFUS
Experimental: Active tFUS targeting the Ventral Striatal Olfactory Tubercle (VSOT)
Active tFUS of the bilateral VSOT randomized at one of the three stimulation visits
Device: transcranial focused ultrasound (tFUS)
non-invasive brain stimulation using tFUS
Sham Comparator: Sham tFUS
Sham tFUS randomized at one of three stimulation visits
Device: transcranial focused ultrasound (tFUS)
non-invasive brain stimulation using tFUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
from the baseline visit until the third follow-up visit (about 1 month)
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
from the baseline visit until the third follow-up visit (about 1 month)
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
from the baseline visit until the third follow-up visit (about 1 month)
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
from the baseline visit until the third follow-up visit (about 1 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
from the baseline visit until the third follow-up visit (about 1 month)
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")
from the baseline visit until the third follow-up visit (about 1 month)
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
from the baseline visit until the third follow-up visit (about 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00150452
  • 1R21DC023711-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results (raw data and summarized) will be shared. A final de-identified data set will be made available for retrieval and analysis through OpenNeuro.org. All study protocols, including detailed descriptions of the study structure, data formats, and analytical methods, will be made available to ensure transparency and reproducibility. Associated documentation, including data dictionaries, codebooks, and analysis scripts, will be provided to enable others to replicate our methodology and build upon our findings. Data will be made available after publication of the findings.

IPD Sharing Time Frame

Data will be made available after publication of the findings. Data will be retained long enough to support the reproducibility of our published findings, the re-use by others, and as long as it is of value to the research community and/or public.

IPD Sharing Access Criteria

Data will be identifiable through a search engine for the title and other key words including the Modality: EEG, Task: odor-enhanced visual processing, Diagnosis: healthy controls, and Study Type: crossover. Additionally, we will provide the Openneuro Accession Number in any study communication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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