Recruiting

tFUS

Sponsor:

Medical University of South Carolina

Code:

NCT07658365

Conditions

Healthy

Olfaction

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

transcranial focused ultrasound (tFUS)

Study Details

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

Study ID

NCT07658365

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Active tFUS targeting the Amygdala (AMYG)

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

experimental: Active tFUS targeting the Ventral Striatal Olfactory Tubercle (VSOT)

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

sham comparator: Sham tFUS

Sham tFUS randomized at one of three stimulation visits

Interventions

transcranial focused ultrasound (tFUS)

non-invasive brain stimulation using tFUS

Primary outcome measure

  • Odor Valence Rating [ Time Frame: 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) ]
  • Sniff Volume [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Nicole Cash, Study Coordinator

843-790-3449cashni@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Nicole Cash

8437903449cashni@musc.edu

Aly Grella

8437903449grella@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.