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

Sponsor
University of Catania
Study ID
NCT06020937
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • TDI — DIAGNOSTIC_TEST
    Sniffin' Sticks Threshold and Identification Test
  • Trigeminal Test — DIAGNOSTIC_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 — DIAGNOSTIC_TEST
    Montreal Cognitive assessment
  • Anxiety and Depression questionnaire — DIAGNOSTIC_TEST
    Specific 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_TEST
    Patients will answer to a validated questionnaire

Study Details

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.

Key Dates

First listed
Sep 1, 2023
Start date
May 30, 2026
Status verified
May 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Control
    Healthy patients
  • Arm: Multiple Sclerosis 1
    Patients with multiple Sclerosis and Trigeminal disorders
  • Arm: Multiple Sclerosis 2
    Patients with Multiple Sclerosis without trigeminal concerns

Primary Outcome Measure

Trigeminal component [ Time Frame: 12 months ]

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