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Starting soon Observational

Olfactory and Trigeminal Functions in Patients With Multiple Sclerosis: Case-control Study

NCT06020937 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-05-30
Last updated
2026-05-12

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

TDITrigeminal TestCognitive Evaluation by Montreal Cognitive AssessmentAnxiety and Depression questionnaireVisual Analogue Scale RatingsQuality of smell Questionnaire

TDI: Sniffin' Sticks Threshold and Identification Test

Trigeminal Test: Test the trigeminal smell answer by a device that releases air and a substance that stimulates the trigeminal response

Cognitive Evaluation by Montreal Cognitive Assessment: Montreal Cognitive assessment

Anxiety and Depression questionnaire: Specific test to evaluate patient's mood

Visual Analogue Scale Ratings: * Smell ability (How is your sense of smell right now? 0 cannot smell, 1-3 severe impairment, 4-6 moderate impairment, 7-9 mild impairment, 10 normal) * Nasal breathing (How well can you breathe through your nose right now? 0 complete nasal obstruction, 1-3 severe impairment, 4-6 moderate impairment, 7-9 mild impairment, 10 normal)

Quality of smell Questionnaire: Patients will answer to a validated questionnaire

Study summary

The sensation of smell is influenced by the somatosensory and chemesthetic sensati¬ons of the nose: for example, the cooling sensation of menthol or the prickle of carbon dioxide from carbonated drinks. These sensations are mediated in the nose by the trigeminal nerve and there is increasing evidence that trigeminal and olfactory functions are closely linked and potentially interdependent. In addition, trigeminal activation is crucial to the perception of nasal airflow. Some researchers speculate about the impact of trigeminal nerve on the entire olfactory sensation and about the presence of some specific "trigeminal cells" into the nose.Patients with Multiple sclerosis (MS) can suffer from quantitative olfactory disorders that generally are of light entity and do not interfere with daily life activities but it is important to underline that olfactory loss can be an onset sign of the MS. Considering the "trigeminal component" in the olfaction, because trigeminal nerve inflammation is quite common in MS patients due to central and peripheral inflammation, it could be possible that these patients suffer from changes in the quantitative, but more in the qualitative smell functions that are generally not identified because poorly investigated.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: Adult women (age 18 to 55) diagnosed with multiple sclerosis using the 2017 McDonald Criteria under treatment with Disease Modifying Therapy (DMTs) with or without trigeminal concerns, or newly diagnosed with MS Exclusion Criteria: * Chronic rhinosinusitis with and without nasal polyposis; current allergic rhinitis; other nasal issues that lead to olfactory dysfunction * anamnestic COVID with incomplete recovery * Neurodegenerative disorders (Parkinson, Alzheimer, Fronto-temporal Dementia, cognitive impairment and brain vascular diseases) * History of stroke in the last three years * Depression or any psychiatric condition * intake of drugs with sedating side effects * major health issues that might affect olfactory function (e.g., significant renal insufficiency, uncontrolled diabetes) * Chronic alcoholism / drug abuse * Severe head trauma * Severe facial injuries * Smoker over 20 cigarettes day or smoking from more than 15 years

Primary outcome measure(s)

  • Trigeminal component — 12 months
    One bottle contains 10ml Eucalyptol (pure / 99%), the other bottle contains only air 15ml stimuli would be released from both bottles using the squeezer device A 3cm long, 4mm inner diameter silicon tubing is placed over the nozzle of each bottle to minimize irritation at the nostrils Silicon tubing should reach beyond the nasal valve area * Trigeminal intensity ratings (How intense is the tickling or cool sensation in the nose? 0 no feeling, 10 very strong feeling) * The trial can be done on the left nostril, then on the right nostril and this already corresponds to the first presentation for the actual test * Total of 20 presentations (10 on each side) with interstimulus interval of around 10 seconds between each presentation, and a longer pause of 30 seconds every 5 presentations * The score is the sum of correct lateralizations

Trial sites (1)

FacilityCityRegionStatus
Arianna Di Stadio Catania Sicily
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06020937 on ClinicalTrials.gov ↗ ← All trials in Italy