Corticosteroid Pulse Therapy Effects on MRI Asymptomatic Gadolinium-enhancing Lesions Conversion to a Non-enhancing Black Hole With or Without Treatment in MS Clinic of Booalisina Hospital Sari 2021-2023
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of black hole
研究概览
简要总结
to determine the rate of asymptomatic gadolinium-enhancing lesions conversion to the non-enhancing black hole (neBHs) with or without corticosteroid pulse therapy in patients with RRMS, and to analyze if treatment of asymptomatic gadolinium enhancement lesions has any effect on the expanded disability status scale. The study is performed in the MS clinic of Bu Ali Sina Hospital in Sari and Mazandaran University of Medical Sciences. 104 recurrent MS patients are admitted based on the admission criteria. They are divided into two groups of intervention and control based on a simple randomization block. The intervention group received 1 gram of methylprednisolone in 500 ccs of normal saline for 5 days and the control group received only 500 ccs of serum. After 6 months, a new MRI is taken from the patients and the possibility of asymptomatic active plaque conversion with or without intervention is compared in the two groups, as well as the amount of EDSS in the two groups. They do not know whether the patient is in the control group or the intervention.
详细描述
Investigators perform a study on 104 consecutive patients with a diagnosis of RR-MS. Participants will be selected for the study if they meet all of the following inclusion criteria: (1) a baseline MRI scan with at least one CEL on contrast-enhanced T1-weighted images (performed either at the time of the diagnosis or during the routine MRI monitoring of the disease) and (2) a follow-up MRI scan performed at least 6 months later in the same hospital site. Participants were then divided into two groups by block randomization (the Block size will be 4): (1) participants with asymptomatic CELs, treated with a single cycle of high-dose IVMP after baseline MRI (group A) and (2) participants with asymptomatic CELs for clinical relapse and, therefore, not exposed to IVMP after baseline MRI (group B).
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Microsoft Excel software will be used for block randomization with a group of 4.
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Number the participants from 1 to 102.
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In a group of 2, the possible combinations of blocks are:(A=Group1 and B=Group2)
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ABBA 2. ABAB 3. BBAA 4. ABAB 5. BAAB 6. BABA
To determine the sample size for this study we used the result of Maria Di Gregorio and et al.
This study will be double-blind patients and radiologist clinicians unaware of types of interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with a diagnosis of RR-MS
- •with a baseline MRI scan with at least one asymptomatic CEL on contrast-enhanced T1-weighted images
排除标准
- •Pulse therapy 3 months ago,
- •More than 6 months ago slowly progressive disease
- •Systemic infections, including fungal infection
- •Uncontrolled hypertension
- •With known hypersensitivity to the steroid preparation
研究组 & 干预措施
The intervention group
The intervention group will receive 1 gram of methylprednisolone succinate within 500 ccs of normal saline within 5 hours.
干预措施: Methylprednisolone succinate (Drug)
The intervention group
The intervention group will receive 1 gram of methylprednisolone succinate within 500 ccs of normal saline within 5 hours.
干预措施: Normal saline (Drug)
The control group
The control group will receive 500 g of normal saline without methylprednisolone succinate.
干预措施: Methylprednisolone succinate (Drug)
The control group
The control group will receive 500 g of normal saline without methylprednisolone succinate.
干预措施: Normal saline (Drug)
结局指标
主要结局
Number of black hole
时间窗: After 6 months
NeBH (to non-enhancing black hole) was defined as an area of unequivocal low signal intensity compared with normal-appearing white matter that did not show contrast uptake and was concordant with a hyperintense lesion seen on T2-weighted imaging.They have also been defined as T1-hypointensities persisting for more than 6 months after their appearance
Expanded disability status scale
时间窗: After 6 months
The EDSS quantifies disability in eight functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. It ranges from 1.0 to 4.5 for people affected with MS who are fully ambulatory, and from 5.0 to 9.5 for people with MS with impaired ambulation. The maximum grade, 10.0, represents death due to MS
次要结局
未报告次要终点
研究者
Seyed Mohammad Baghbanian
Seyed Mohammad Baghbanian
Mazandaran University of Medical Sciences