Clinical trial NCT05973929: Movement Disorders in Multiple Sclerosis Patients
Official title: Clinical and Radiological Evaluation of Movement Disorders in Multiple Sclerosis Patients.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Movement Disorders
Keywords: Multiple sclerosis
Movement Disorders
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017.

Brief summary: The aim of this study is to determine the prevalence of movement disorders in MS patients.

Also,To know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients. Moreover, to find the correlation between the movement disorder and the different types of MS.

Detailed description: A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017 (Thompson et al. 2018).

The investigators will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria:

i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not).

iv. MRI Brain and spine of the included patient will be photographed.

Exclusion criteria:

1. Patients with multiple sclerosis mimics which can cause movement disorders e.g., systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or CNS infection.
2. patients with primary movement disorders or related to other neurodegenerative diseases.

Eligibility criteria: Inclusion Criteria:

- We will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria: i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not).

iv. MRI Brain and spine of the included patient will be photographed.

Exclusion Criteria:

- 1-Patients with multiple sclerosis mimics which can cause movement disorders e.g., systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or CNS infection.

2-patients with primary movement disorders or related to other neurodegenerative diseases.

Primary outcomes:
measure: Determine the prevalence of movement disorders in MS patients.
timeFrame: Through study completion, an average of 1.5 year
measure: know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients.
timeFrame: Through study completion, an average of 1.5 year
measure: find the correlation between the movement disorder and the different types of MS.
timeFrame: Through study completion, an average of 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mostafa Mahmoud Hassan Meshref
state: Select A State Or Province
Study officials:
References:
citation: Abboud H, Yu XX, Knusel K, Fernandez HH, Cohen JA. Movement disorders in early MS and related diseases: A prospective observational study. Neurol Clin Pract. 2019 Feb;9(1):24-31. doi: 10.1212/CPJ.0000000000000560.
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citation: Nociti V, Bentivoglio AR, Frisullo G, Fasano A, Soleti F, Iorio R, Loria G, Patanella AK, Marti A, Tartaglione T, Tonali PA, Batocchi AP. Movement disorders in multiple sclerosis: Causal or coincidental association? Mult Scler. 2008 Nov;14(9):1284-7. doi: 10.1177/1352458508094883. Epub 2008 Sep 3.
citation: Oakes PK, Srivatsal SR, Davis MY, Samii A. Movement disorders in multiple sclerosis. Phys Med Rehabil Clin N Am. 2013 Nov;24(4):639-51. doi: 10.1016/j.pmr.2013.06.003. Epub 2013 Aug 27.
citation: Suarez-Cedeno G, Mehanna R. Movement Disorders in Multiple Sclerosis and Other Demyelinating Diseases: A Retrospective Review From a Tertiary Academic Center. Neurologist. 2021 Sep 7;26(5):161-166. doi: 10.1097/NRL.0000000000000333.
citation: Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
citation: GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Mar;18(3):269-285. doi: 10.1016/S1474-4422(18)30443-5. Epub 2019 Jan 21.
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