Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT): Open Label
Medical University of South Carolina
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.
Description
Smell dysfunction is a serious health issue associated with everyday dangers like the inability to correctly identify nearby hazards (e.g. burning, gas leaks, or spoiled food), psychosocial problems including social withdrawal and reduced quality and enjoyment of life, a myriad of psychiatric conditions, and a generally increased risk of mortality. Further escalating the gravity of olfactory dysfunction is mounting evidence of olfactory disturbance as prodromal to neurodegenerative disorder. Smell/olfactory training (ST) has emerged as the first-line, and only (current) treatment for smell lo…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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) *…
Interventions
- Combination ProductTrigeminal Nerve Stimulation-enhanced Smell Training
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.
Location
- Medical University of South CarolinaCharleston, South Carolina