NCT06020937

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

Olfactory and Trigeminal Functions in Patients With Multiple Sclerosis

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University of Catania · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

From a theoretically point of view pain in the trigeminal nerve increases the surrounding perception, including the perception of the odors. It has been shown that by using sweet food it is possible to reduce the level of pain; on the other side, sweet food in contrast to the bitter one was able to reduce the sensation of odor unpleasantness present with pain increase. To date no studies have investigated the relationship between trigeminal inflammation, odors and pain in a cohort of patients with MS. This study aims at investigating the possible correlation between alteration in trigeminal functions and perception of odors using Sniffin' Stick Threshold, Detection and Identification test and quality smell questionnaire in a sample of healthy patients compared to MS patients.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	TDI	Sniffin' Sticks Threshold and Identification Test
DIAGNOSTIC_TEST	Trigeminal Test	Test the trigeminal smell answer by a device that releases air and a substance that stimulates the trigeminal response
DIAGNOSTIC_TEST	Cognitive Evaluation by Montreal Cognitive Assessment	Montreal Cognitive assessment
DIAGNOSTIC_TEST	Anxiety and Depression questionnaire	Specific test to evaluate patient's mood
DIAGNOSTIC_TEST	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)
DIAGNOSTIC_TEST	Quality of smell Questionnaire	Patients will answer to a validated questionnaire

Timeline

• Start date: 2024-10-30
• Primary completion: 2025-07-30
• Completion: 2026-12-30
• First posted: 2023-09-01
• Last updated: 2024-05-08

Locations

1 site across 1 country: Italy