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

NCT07689773 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: Pro00151125
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Olfactory Impairment

Keywords

olfaction; smell loss; chronic rhinosinusitis; olfactory dysfunction; smell training; olfactory training; trigeminal nerve stimulation; sensory loss

Outcome Measures

Primary Outcomes (5)

• Change in Psychophysical Olfactory Function from Baseline to 4 and 8 Weeks

  Sniffin' Sticks (Bughardt Messtechnik, Wedel Germany) will be used to determine odor threshold (T), odor discrimination (D), and odor identification (I), each on 16-point scales, and summed for a total TDI score. Higher scores indicate better function.

  8 weeks

• Change in Perceived Intensity of Odorants from Baseline to 4 and 8 Weeks

  Perceived intensity on 100-mm visual analog scales with anchor points: 0="imperceptible" to 100="extremely intense".

  8 weeks

• Change in Perceived Hedonics of Odorants from Baseline to 4 and 8 Weeks

  Perceived hedonics on 100-mm visual analog scales with anchor points: 0="extremely unpleasant" to 100="extremely pleasant".

  8 weeks

• Change in Olfactory-related Quality of Life from Baseline to 4 and 8 Weeks

  The Modified Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) consists of 17 negative statements (rated on a scale from 0 to 3; total score ranging from 0 to 51), with lower scores indicating better olfactory-related quality of life.

  8 weeks

• Change in Impact of Olfactory Loss from Baseline to 4 and 8 Weeks

  The Impact of Olfactory Loss Visual Analog Scale (IOL-VAS) consists of 9 separate items assessing the impact of olfactory loss upon mood, food enjoyment, social interactions, safety, hygiene, sex, cooking, appetite, and weight changes, rated from 0 (no impact) to 10 (biggest impact possible).

  8 weeks

Secondary Outcomes (4)

• Change in Mood State from Baseline to 4 and 8 Weeks

  8 weeks

• Change in Sleep Quality from Baseline to 4 and 8 Weeks

  8 weeks

• Change in Symptoms of Depression from Baseline to 4 and 8 Weeks

  8 weeks

• Change in Symptoms of Anxiety from Baseline to 4 and 8 Weeks

  8 weeks

Study Arms (1)

Open Label Trigeminal Nerve Stimulation-enhanced Smell Training (TNS-enhanced ST)

EXPERIMENTAL

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.

Combination Product: Trigeminal Nerve Stimulation-enhanced Smell Training

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.

Open Label Trigeminal Nerve Stimulation-enhanced Smell Training (TNS-enhanced ST)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Self-reported or medically documented smell loss
• Treatment-seeking for their smell loss
• Naïve to TNS
• Able to comprehend English and provide informed consent

You may not qualify if:

• Medical Records not available to confirm eligibility
• Documented/Suspected head injury (e.g. sport, accident, blast exposure)
• Neurological disorder (e.g. epilepsy, neurodegenerative disorder)
• Serious mental illness (e.g. schizophrenia, bipolar disorder)
• Suicidal ideation within the last month
• Current (≤6 months) and/or heavy cigarette smokers (i.e. ≥ 10 pack-years)
• Oral/nasal steroids or other intranasal medications
• Immunomodulatory medications
• Pregnant or trying to become pregnant

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Olfaction Disorders; Anosmia

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

US (1)