Olfactory Transcranial Focused Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial focused ultrasound (tFUS).
- Who it may be relevant to
- Registry conditions: Healthy, Olfaction. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Modulation of Olfactory Valence by Transcranial Focused Ultrasound (tFUS)
Overview
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.
Interventions
- Device transcranial focused ultrasound (tFUS)
non-invasive brain stimulation using tFUS
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 30762663
- 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
Identifiers
NCT: NCT07658365 · Pro00150452 · 1R21DC023711-01