NCT04157283|Unknown
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Sponsor study identifier
observational
120
1 country
1
Study Start
November 5, 2019
Actual (reported)Primary Completion
May 5, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This work aims to:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2019
Actual (reported)November 5, 2019
Actual (reported)November 8, 2019
Actual (reported)May 5, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The Sexual Quality of Life-Male (SQOL-M)
Assesses the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best)-completely Agree = 1 to Completely Disagree = 6. The total score can range from 11 to 66 points.
24-48 hours
The Sexual Quality of Life-Female (SQOL-F)
Assesses the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life.
24-48 hours
The international index of erectile function (IIEF)
It's formed of 15 questions about main domains of male sexual function and each one had a score of 0-5 but used in Arabic translation.
24-48 hours
Beck's Depression Inventory
24-48 hours
Fatigue symptoms
24-48 hours
60 male patients
60 female patients
1. Neurophysiological Evaluation: Visual Evoked Potential (VEP). 2. Imaging Evaluation: Conventional MRI. 3. Cerebrospinal Fluid (CSF): 4. Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994). 5. Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression. 6. Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
2) Chan,K.,& Tsang, L. (2011). Promote healthy eating among adolescents:A Hong Kong study . Journal of Consumer Marketing, 28(5), 354-362.
Fangerau T, Schimrigk S, Haupts M, Kaeder M, Ahle G, Brune N, Klinkenberg K, Kotterba S, Mohring M, Sindern E; Multiple Sclerosis Study Group. Diagnosis of multiple sclerosis: comparison of the Poser criteria and the new McDonald criteria. Acta Neurol Scand. 2004 Jun;109(6):385-9. doi: 10.1111/j.1600-0404.2004.00246.x.
Esmael M Ahmed, MD
Assistant Prof of Neurology
First Submitted
November 5, 2019
First Posted
November 8, 2019
Study Start
November 5, 2019
Actual (reported)Primary Completion
May 5, 2020
Estimated (date passed)The Impact of Body Weight on Clinical and Immunological Outcomes in Relapse-Remitting Multiple Sclerosis Patients
Contact the study team to confirm eligibility.
Fraser C, Mahoney J, McGurl J. Correlates of sexual dysfunction in men and women with multiple sclerosis. J Neurosci Nurs. 2008 Oct;40(5):312-7. doi: 10.1097/01376517-200810000-00010.
Freedman MS, Thompson EJ, Deisenhammer F, Giovannoni G, Grimsley G, Keir G, Ohman S, Racke MK, Sharief M, Sindic CJ, Sellebjerg F, Tourtellotte WW. Recommended standard of cerebrospinal fluid analysis in the diagnosis of multiple sclerosis: a consensus statement. Arch Neurol. 2005 Jun;62(6):865-70. doi: 10.1001/archneur.62.6.865.
Kesselring J, Beer S. Symptomatic therapy and neurorehabilitation in multiple sclerosis. Lancet Neurol. 2005 Oct;4(10):643-52. doi: 10.1016/S1474-4422(05)70193-9.
Lew-Starowicz M, Gianotten WL. Sexual dysfunction in patients with multiple sclerosis. Handb Clin Neurol. 2015;130:357-70. doi: 10.1016/B978-0-444-63247-0.00020-1.
Marrie RA. Environmental risk factors in multiple sclerosis aetiology. Lancet Neurol. 2004 Dec;3(12):709-18. doi: 10.1016/S1474-4422(04)00933-0.
Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
Zivadinov R, Zorzon M, Bosco A, Bragadin LM, Moretti R, Bonfigli L, Iona LG, Cazzato G. Sexual dysfunction in multiple sclerosis: II. Correlation analysis. Mult Scler. 1999 Dec;5(6):428-31. doi: 10.1177/135245859900500i610.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 8, 2019
Record last verified: 2019-11
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