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

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 10, 2026

Status verified

Aug 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

• Experimental: 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 ]

Central Contacts

• Bernadette Cortese, PhD
  8437926922
  [email protected]

Locations (1)

Find similar trials in Charleston, SC

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