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IRCT20220803055606N4 IRCT 2026-06-03 Shahid Beheshti University of Medical Sciences Comparison of two methylprednisolone pulse regimens on sleep quality in patients with multiple sclerosis MS-MP Sleep Trial Investigating the effect of methylprednisolone pulse administration regimen on sleep quality in patients with multiple sclerosis admitted to Loghman Hakim Hospital in 2026 2026-06-22 anticipated 40 Complete https://irct.ir/trial/90440 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is designed as a randomized, two-arm, parallel-group clinical trial with a pre-test/post-test design. Both groups receive standard methylprednisolone pulse therapy, and the main difference between the groups is the dosing schedule. One group receives intravenous methylprednisolone 500 mg twice daily every 12 hours, while the other group receives 1000 mg once daily. Therefore, there is no placebo group, and the study aims to compare the effects of two active administration regimens on sleep quality and cognitive performance in patients with multiple sclerosis. Outcomes are assessed before treatment initiation and after completion of the intervention using the Insomnia Severity Index questionnaire, the Montreal Cognitive Assessment test, and the Rey Osterrieth Complex Figure Test, Randomization description: Eligible patients will be randomly allocated in a 1:1 ratio to one of the two treatment groups. The randomization sequence will be generated using a computer-generated random list or random number table. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. N/A Multiple sclerosis. Intervention 1: Intervention group: Group 1: Patients in this group will receive intravenous methylprednisolone 500 mg twice daily every 12 hours, with a total daily dose of 1000 mg. Intervention 2: Intervention group: Group 2: Patients in this group will receive intravenous methylprednisolone 1000 mg once daily. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of patients’ clinical information and ethical restrictions regarding individual participant data, the individual participant dataset will not be publicly shared. Data will be analyzed in coded form, and only aggregate, non identifiable results will be published as a thesis or scientific article.
public Dr. Seyedeh Zahra Hashemi
Neurology Ward, Loghman Hakim Hospital, Kamali St, Lashgar Crossroads
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 hashemi.zahra.90@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Seyedeh Zahra Hashemi
Neurology Ward, Loghman Hakim Hospital, Kamali St, Lashgar Crossroads
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 hashemi.zahra.90@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with definite diagnosis of multiple sclerosis confirmed by a neurologist, indication for methylprednisolone pulse therapy, age above 18 years, admission to the neurology ward of Loghman Hakim Hospital, and written informed consent will be included. 18 years no limit Both Severe psychiatric disorders, concomitant use of sleep-affecting medications such as benzodiazepines, inability or unwillingness to complete questionnaires, lack of informed consent, and severe drug-related adverse events requiring discontinuation of treatment. G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: Group 1: Patients in this group will receive intravenous methylprednisolone 500 mg twice daily every 12 hours, with a total daily dose of 1000 mg. Intervention group: Group 2: Patients in this group will receive intravenous methylprednisolone 1000 mg once daily. Change in Insomnia Severity Index questionnaire score. Timepoint: Before starting methylprednisolone pulse therapy and after completion of treatment. Method of measurement: The standard Insomnia Severity Index questionnaire includes 7 items with a score range from 0 to 28. Change in global cognitive function score in patients with multiple sclerosis. Timepoint: Before starting treatment and after completion of the intervention. Method of measurement: Using the Montreal Cognitive Assessment test, with a score range from 0 to 30. Change in visuospatial memory, planning, and cognitive organization score in patients with multiple sclerosis. Timepoint: Before starting treatment and after completion of the intervention. Method of measurement: Using the Rey Osterrieth Complex Figure Test through copying and recall of the complex figure. Change in insomnia severity category in patients with multiple sclerosis, including normal status, mild insomnia, moderate insomnia, and severe insomnia. Timepoint: Before starting treatment and after completion of the intervention. Method of measurement: Using the Insomnia Severity Index questionnaire, including 7 items with a score range from 0 to 28; scores 0 to 7 are considered normal, 8 to 14 mild insomnia, 15 to 21 moderate insomnia, and 22 to 28 severe insomnia. Shahid Beheshti University of Medical Sciences Approved 2025-12-16 Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences Next to Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)