Health TrialsbyHealthPanel

Olfactory Transcranial Focused Ultrasound

ConditionsHealthyOlfaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-65 years

Healthy adult volunteers

Normal olfactory function (Sniffin' Sticks total TDI ≥ 30.75)

Ability to provide informed consent

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • transcranial focused ultrasound (tFUS)

    Device

    non-invasive brain stimulation using tFUS

Treatment groups

28 Participants
are divided into 3 treatment groups
Group A: Active tFUS targeting the Amygdala (AMYG)Experimental treatment 1 intervention
Group B: Active tFUS targeting the Ventral Striatal Olfactory Tubercle (VSOT)Experimental treatment 1 intervention
Group C: Sham tFUSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Odor Valence Rating

Participant rating of odor pleasantness on a 0-100 mm visual analog scale (e.g., unpleasant → pleasant)

Time frame
from the baseline visit until the third follow-up visit (about 1 month)
2

Late Positive Potential

Mean EEG amplitude (400-800 ms) at centro-parietal sites to olfactory-visual stimuli

Time frame
from the baseline visit until the third follow-up visit (about 1 month)
3

Sniff Volume

Total nasal airflow (in mL) per odor trial, measured via nasal cannula or spirometer

Time frame
from the baseline visit until the third follow-up visit (about 1 month)
4

Corrugator Supercilii EMG Activity

Mean EMG amplitude from facial muscle sensitive to negative affect and aversion

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

Secondary outcomes

1

Odor Intensity Rating

Participant rating of odor intensity on a 0-100 mm visual analog scale (e.g., not at all → extremely)

Time frame
from the baseline visit until the third follow-up visit (about 1 month)
2

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")

Time frame
from the baseline visit until the third follow-up visit (about 1 month)
3

Sniff Rate

Breaths per min or per trial window in response to odor exposure

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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