HealthyO-tFUSNCT07658365
Olfactory Transcranial Focused Ultrasound
A study testing transcranial focused ultrasound (tFUS) in people with Healthy and Olfaction, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- transcranial focused ultrasound (tFUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Nicole Cash, 8437903449, cashni@musc.edu
Aly Grella, 8437903449, grella@musc.edu
About this study
Official title: 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.
- Being tested
- transcranial focused ultrasound (tFUS)
- Keywords
- healthy volunteer, electroencephalography (EEG), magnetic resonance imaging (MRI), odors
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial focused ultrasound (tFUS)Device
non-invasive brain stimulation using tFUS
| Study group | Role | What they receive |
|---|---|---|
| Active tFUS targeting the Amygdala (AMYG) | Experimental | Active tFUS of the bilateral Amygdala randomized at one of the three stimulation visits Receives: Device: transcranial focused ultrasound (tFUS) |
| Active tFUS targeting the Ventral Striatal Olfactory Tubercle (VSOT) | Experimental | Active tFUS of the bilateral VSOT randomized at one of the three stimulation visits Receives: Device: transcranial focused ultrasound (tFUS) |
| Sham tFUS | Sham comparator | Sham tFUS randomized at one of three stimulation visits Receives: Device: transcranial focused ultrasound (tFUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odor Valence Rating
Participant rating of odor pleasantness on a 0-100 mm visual analog scale (e.g., unpleasant → pleasant)
Measured: from the baseline visit until the third follow-up visit (about 1 month)
Late Positive Potential
Mean EEG amplitude (400-800 ms) at centro-parietal sites to olfactory-visual stimuli
Measured: from the baseline visit until the third follow-up visit (about 1 month)
Sniff Volume
Total nasal airflow (in mL) per odor trial, measured via nasal cannula or spirometer
Measured: from the baseline visit until the third follow-up visit (about 1 month)
Corrugator Supercilii EMG Activity
Mean EMG amplitude from facial muscle sensitive to negative affect and aversion
Measured: from the baseline visit until the third follow-up visit (about 1 month)
Secondary outcomes (3)
Odor Intensity Rating
Participant rating of odor intensity on a 0-100 mm visual analog scale (e.g., not at all → extremely)
Measured: from the baseline visit until the third follow-up visit (about 1 month)
Odor Avoidance Rating
Participant rating of their desire to avoid the odor on a 0-100 mm visual analog scale (e.g., "not at all" → "extreme")
Measured: from the baseline visit until the third follow-up visit (about 1 month)
Sniff Rate
Breaths per min or per trial window in response to odor exposure
Measured: from the baseline visit until the third follow-up visit (about 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Oct 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Bernadette Cortese, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658365
- Sponsor's protocol ID
- Pro00150452
- Other IDs
- 1R21DC023711-01
- Acronym
- O-tFUS
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Houghton DC, Uhde TW, Borckardt JJ, Cortese BM. Exploratory Investigation of a Brief Cognitive Behavioral Intervention and Transcranial Direct Current Stimulation on Odor Sensitivity. Psychosom Med. 2019 May;81(4):389-395. doi: 10.1097/PSY.0000000000000679.
PubMed 30762663Badran BW, Gruber EM, O'Leary GH, Austelle CW, Huffman SM, Kahn AT, McTeague LM, Uhde TW, Cortese BM. Electrical stimulation of the trigeminal nerve improves olfaction in healthy individuals: A randomized, double-blind, sham-controlled trial. Brain Stimul. 2022 May-Jun;15(3):761-768. doi: 10.1016/j.brs.2022.05.005. Epub 2022 May 11.
PubMed 35561963
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Olfactory Valence by Transcranial Focused Ultrasound (tFUS)
- ClinicalTrials.gov ID
- NCT07658365
- Acronym / sponsor ID
- O-tFUS / Pro00150452
- Keywords
- healthy volunteer, electroencephalography (EEG), magnetic resonance imaging (MRI), odors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active tFUS targeting the Amygdala (AMYG) | Experimental | Device: transcranial focused ultrasound (tFUS)Active tFUS of the bilateral Amygdala randomized at one of the three stimulation visits |
| Active tFUS targeting the Ventral Striatal Olfactory Tubercle (VSOT) | Experimental | Device: transcranial focused ultrasound (tFUS)Active tFUS of the bilateral VSOT randomized at one of the three stimulation visits |
| Sham tFUS | Sham comparator | Device: transcranial focused ultrasound (tFUS)Sham tFUS randomized at one of three stimulation visits |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial focused ultrasound (tFUS)non-invasive brain stimulation using tFUS | Device | Active tFUS targeting the Amygdala (AMYG), Active tFUS targeting the Ventral Striatal Olfactory Tubercle (VSOT), Sham tFUS |
Primary outcome
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)
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
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
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
3 secondary outcomes
Odor Intensity Rating
Time frame: 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)
Sniff Rate
Time frame: from the baseline visit until the third follow-up visit (about 1 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 30762663Houghton DC, Uhde TW, Borckardt JJ, Cortese BM. Exploratory Investigation of a Brief Cognitive Behavioral Intervention and Transcranial Direct Current Stimulation on Odor Sensitivity. Psychosom Med. 2019 May;81(4):389-395. doi: 10.1097/PSY.0000000000000679.
- Background: PubMed 35561963Badran BW, Gruber EM, O'Leary GH, Austelle CW, Huffman SM, Kahn AT, McTeague LM, Uhde TW, Cortese BM. Electrical stimulation of the trigeminal nerve improves olfaction in healthy individuals: A randomized, double-blind, sham-controlled trial. Brain Stimul. 2022 May-Jun;15(3):761-768. doi: 10.1016/j.brs.2022.05.005. Epub 2022 May 11.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial focused ultrasound (tFUS) in people with Healthy and Olfaction, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Cash, Study Coordinator (843-790-3449, cashni@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odor Valence Rating (time frame: from the baseline visit until the third follow-up visit (about 1 month)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07658365, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.