Olfactory Transcranial Focused Ultrasound

NCT07658365 | Not Yet Recruiting

• 2 other identifiers: Pro001504521R21DC023711-01
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy; Olfaction

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Odor Valence Rating

  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

  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

  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

  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 Outcomes (3)

• Odor Intensity Rating

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

• Odor Avoidance Rating

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

• Sniff Rate

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

Study Arms (3)

Active tFUS targeting the Amygdala (AMYG)

EXPERIMENTAL

Active tFUS of the bilateral Amygdala randomized at one of the three stimulation visits

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

Device: transcranial focused ultrasound (tFUS)

Sham tFUS

SHAM COMPARATOR

Sham tFUS randomized at one of three stimulation visits

Device: transcranial focused ultrasound (tFUS)

Interventions

transcranial focused ultrasound (tFUS) DEVICE

non-invasive brain stimulation using tFUS

Active tFUS targeting the Amygdala (AMYG); Active tFUS targeting the Ventral Striatal Olfactory Tubercle (VSOT); Sham tFUS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• National Institutes of Health (NIH): collaborator

Related Publications (2)

• 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.

  PMID: 30762663 BACKGROUND

• Badran 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.

  PMID: 35561963 BACKGROUND

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nicole Cash, Study Coordinator

CONTACT

843-790-3449; cashni@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.