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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorUniversity of Catania

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Control4 interventions
Group B: Multiple Sclerosis 16 interventions
Group C: Multiple Sclerosis 26 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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