Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT): Open Label

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07689773
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Olfactory Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Trigeminal Nerve Stimulation-enhanced Smell Training — COMBINATION_PRODUCT
    TNS is a form of cranial nerve stimulation that uses a simple transcutaneous electrical nerve stimulation device, and adhesive electrodes that are attached to forehead to deliver low-level electrical current. Stimulating the trigeminal nerve activates the trigeminal afferent sensory pathway and central brain regions where the intranasal trigeminal and olfactory circuits converge. Smell Training requires 4 odors to be smelled individually for 10 sec each and record ratings.

Study Details

Smell dysfunction significantly impacts quality of life and safety, with limited effective treatments. This open-label study evaluates the preliminary efficacy of combining non-invasive trigeminal nerve stimulation (TNS) with standard smell training (ST) to improve olfactory function. Participants will complete 8 weeks of at-home treatment and attend three in-person visits for assessment. Improvements in smell, mood, sleep, and quality of life will be measured.

Key Dates

First listed
Jul 8, 2026
Start date
Jul 8, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Open Label Trigeminal Nerve Stimulation-enhanced Smell Training (TNS-enhanced ST)
    TNS-enhanced ST will be administered at-home 5 days/week for 8 weeks. Participants will self-administer the first treatment of TNS-enhanced ST with the assistance and help of study staff. This includes attaching the gel pads to the forehead and turning the TNS system on for 30-min., training with different odorants and providing ratings on a website called REDCap, an easy-to-use, secure, internet-based data collection site.

Primary Outcome Measure

Change in Psychophysical Olfactory Function from Baseline to 4 and 8 Weeks [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Bernadette Cortese, Ph.D.
[email protected]
843-792-6922

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By research site
Medical University of South Carolina· Charleston, SC

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