Olfactory and Trigeminal Functions in Patients With Multiple Sclerosis: Case-control Study
NCT ID: NCT06020937
Last Updated: 2024-05-08
Study Results
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Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2024-10-30
2026-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control
Healthy patients
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
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
Multiple Sclerosis 1
Patients with multiple Sclerosis and Trigeminal disorders
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
Multiple Sclerosis 2
Patients with Multiple Sclerosis without trigeminal concerns
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
55 Years
FEMALE
Yes
Sponsors
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University of Roma La Sapienza
OTHER
Hospital General Universitario Santa Lucia
OTHER
Klinik und Poliklinik fur Kinderheilkunde
OTHER
University of Catania
OTHER
Responsible Party
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Arianna Di Stadio
Associate Professor (temporary)
Locations
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Arianna Di Stadio
Catania, Sicily, Italy
Countries
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Facility Contacts
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Arianna Di Stadio
Role: primary
References
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Hummel T, Frasnelli J. The intranasal trigeminal system. Handb Clin Neurol. 2019;164:119-134. doi: 10.1016/B978-0-444-63855-7.00008-3.
Frasnelli J, Manescu S. The intranasal trigeminal system. In: Buettner A, editor. Dordrecht; 2017. p. 881-95
Hummel T, Iannilli E, Frasnelli J, Boyle J, Gerber J. Central processing of trigeminal activation in humans. Ann N Y Acad Sci. 2009 Jul;1170:190-5. doi: 10.1111/j.1749-6632.2009.03910.x.
Daiber P, Genovese F, Schriever VA, Hummel T, Mohrlen F, Frings S. Neuropeptide receptors provide a signalling pathway for trigeminal modulation of olfactory transduction. Eur J Neurosci. 2013 Feb;37(4):572-82. doi: 10.1111/ejn.12066. Epub 2012 Dec 3.
Doty RL, Brugger WE, Jurs PC, Orndorff MA, Snyder PJ, Lowry LD. Intranasal trigeminal stimulation from odorous volatiles: psychometric responses from anosmic and normal humans. Physiol Behav. 1978 Feb;20(2):175-85. doi: 10.1016/0031-9384(78)90070-7. No abstract available.
Mihara S, Shibamoto T. The role of flavor and fragrance chemicals in TRPA1 (transient receptor potential cation channel, member A1) activity associated with allergies. Allergy Asthma Clin Immunol. 2015 Mar 16;11(1):11. doi: 10.1186/s13223-015-0074-0. eCollection 2015.
Scheibe M, Schulze S, Mueller CA, Schuster B, Hummel T. Intranasal trigeminal sensitivity: measurements before and after nasal surgery. Eur Arch Otorhinolaryngol. 2014 Jan;271(1):87-92. doi: 10.1007/s00405-013-2466-4. Epub 2013 Apr 9.
Zhao K, Jiang J, Blacker K, Lyman B, Dalton P, Cowart BJ, Pribitkin EA. Regional peak mucosal cooling predicts the perception of nasal patency. Laryngoscope. 2014 Mar;124(3):589-95. doi: 10.1002/lary.24265. Epub 2013 Jun 28.
Li C, Farag AA, Maza G, McGhee S, Ciccone MA, Deshpande B, Pribitkin EA, Otto BA, Zhao K. Investigation of the abnormal nasal aerodynamics and trigeminal functions among empty nose syndrome patients. Int Forum Allergy Rhinol. 2018 Mar;8(3):444-452. doi: 10.1002/alr.22045. Epub 2017 Nov 22.
Konstantinidis I, Tsakiropoulou E, Chatziavramidis A, Ikonomidis C, Markou K. Intranasal trigeminal function in patients with empty nose syndrome. Laryngoscope. 2017 Jun;127(6):1263-1267. doi: 10.1002/lary.26491. Epub 2017 Feb 22.
Atalar AC, Erdal Y, Tekin B, Yildiz M, Akdogan O, Emre U. Olfactory dysfunction in multiple sclerosis. Mult Scler Relat Disord. 2018 Apr;21:92-96. doi: 10.1016/j.msard.2018.02.032. Epub 2018 Mar 3.
Zorzon M, Ukmar M, Bragadin LM, Zanier F, Antonello RM, Cazzato G, Zivadinov R. Olfactory dysfunction and extent of white matter abnormalities in multiple sclerosis: a clinical and MR study. Mult Scler. 2000 Dec;6(6):386-90. doi: 10.1177/135245850000600605.
da Silva CJ, da Rocha AJ, Mendes MF, Maia AC Jr, Braga FT, Tilbery CP. Trigeminal involvement in multiple sclerosis: magnetic resonance imaging findings with clinical correlation in a series of patients. Mult Scler. 2005 Jun;11(3):282-5. doi: 10.1191/1352458505ms1186oa.
Riello M, Cecchini MP, Zanini A, Di Chiappari M, Tinazzi M, Fiorio M. Perception of phasic pain is modulated by smell and taste. Eur J Pain. 2019 Nov;23(10):1790-1800. doi: 10.1002/ejp.1453. Epub 2019 Jul 29.
Di Stadio A, Bernitsas E, La Mantia I, Brenner MJ, Ralli M, Vaira LA, Colizza A, Cavaliere C, Laudani M, Frohman TC, De Vincentiis M, Frohman EM, Altieri M. Targeting Neuroinflammation to Alleviate Chronic Olfactory Dysfunction in Long COVID: A Role for Investigating Disease-Modifying Therapy (DMT)? Life (Basel). 2023 Jan 13;13(1):226. doi: 10.3390/life13010226.
Other Identifiers
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UniCT192023
Identifier Type: -
Identifier Source: org_study_id
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