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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DC023711-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tFUS targeting the Amygdala (AMYG) | Experimental | Active tFUS of the bilateral Amygdala randomized at one of the three stimulation visits |
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| Active tFUS targeting the Ventral Striatal Olfactory Tubercle (VSOT) | Experimental | Active tFUS of the bilateral VSOT randomized at one of the three stimulation visits |
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| Sham tFUS | Sham Comparator | Sham tFUS randomized at one of three stimulation visits |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial focused ultrasound (tFUS) | Device | non-invasive brain stimulation using tFUS |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Odor Intensity Rating | Participant rating of odor intensity on a 0-100 mm visual analog scale (e.g., not at all → extremely) | from the baseline visit until the third follow-up visit (about 1 month) |
| Odor Avoidance Rating |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Cash, Study Coordinator | Contact | 843-790-3449 | cashni@musc.edu |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30762663 | Background | 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. | |
| 35561963 | 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. |
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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.
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.
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.
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| ID | Term |
|---|---|
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Participant rating of their desire to avoid the odor on a 0-100 mm visual analog scale (e.g., "not at all" → "extreme")
| 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 | from the baseline visit until the third follow-up visit (about 1 month) |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |