About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
Number of participants: 400, 200 healthy controls, and 200 patients diagnosed with multiple sclerosis divided as follow: 100 with manifest trigeminal pain 100 without known trigeminal pathology.
Trial design
Case-control
Prospective
Treatments tested in this trial
TDI
Diagnostic testSniffin' Sticks Threshold and Identification Test
Trigeminal Test
Diagnostic testTest the trigeminal smell answer by a device that releases air and a substance that stimulates the trigeminal response
Cognitive Evaluation by Montreal Cognitive Assessment
Diagnostic testMontreal Cognitive assessment
Anxiety and Depression questionnaire
Diagnostic testSpecific test to evaluate patient's mood
Visual Analogue Scale Ratings
Diagnostic test* 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
Diagnostic testPatients will answer to a validated questionnaire
Treatment groups
Trial outcomes
Primary outcomes
Trigeminal component
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
Sponsors and contacts
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University of Catania
Lead sponsor
University of Roma La Sapienza
Collaborator
Hospital General Universitario Santa Lucia
Collaborator
Klinik und Poliklinik fur Kinderheilkunde
Collaborator
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