The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients:

The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients: Clinical and Neurophysiology Study.

This work is aimed to assess the short term effect of pulse therapy on clinical and neurophysiological course before and after pulse therapy in order to understand the possible mechanism of action of steroid therapy on RRMS patients low-dose oral treatment should also be retained for patients in whom this approach seems appropriate

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis

Detailed Description

Multiple sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous System (CNS) with a variety of clinical presentations MS affects 2.5 million people worldwide. The profound heterogeneity of MS is not limited to the Symptoms but to neuroradiologic and histologic appearances of lesions and response to therapy.

The terms 'acute attack', 'acute exacerbations', and 'relapses' are used interchangeably and refer to the onset or worsening of neurologic deficits lasting ≥24 hours in the absence of fever or infection. Glucocorticoids are used as first-line treatment for attacks as they provide short-term clinical benefits by reducing the severity and shortening the duration of attacks. Typically, intravenous (IV) methylprednisolone 1 g/day for 3-5 days is given, often followed by an oral course of prednisone beginning at a dose of 60-80 mg/day and then tapered over 2 weeks. Other glucocorticoid considerations are dexamethasone1 and high-dose oral prednisone which appear to be equally effective.

Studies using transcranial magnetic stimulation (TMS) have repeatedly reported white-matter involvement in patients with MS as documented by the prolonged central motor conduction time (CMCT), which can differentiate patients with secondary progressive MS (SPMS) from those with relapsing-remitting MS (RRMS), but didn't correlate with severity or degree of improved motor function after corticosteroid therapy. Also, paired-pulse TMS, when delivered at short interstimulus intervals (ISI) (3-5 ms), the conditioned motor evoked potential (MEP) decreases in amplitude (intracortical inhibition, ICI); besides rMT, AMT, Transcallosal inhibition (TCI)and cortical silent period (CSP).

Previously, electrophysiological and clinical evaluations were performed at the onset of therapy and after the end of treatment using an arbitrary evoked potentials score that found evoked potentials may be useful for monitoring acute Multiple Sclerosis bouts and evaluating the effect of therapy.

However, it is difficult to search for an objective marker of the clinical course, in addition no studies were conducted to evaluate the efficacy and underlying mechanism of pulse therapy on clinical course and outcome of relapsing MS and correlating with these recording changes ( pre and post-pulse therapy) in electrophysiological(both evoked potentials and TMS) studies in relapsing MS. Thus the investigator will conduct this study to understand the mechanism of action of pulse therapy on clinical course and recovery of relapsing MS on short term.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Entsar karem, resident; Phone Number: 0201030698902; Email: entsarkarem07@gmail.com
• Study Contact Backup: Name: Noha M Abo-Elfetoh, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Any adult patient with clinical history and neuroimaging who is fulfilling revised McDonald diagnostic criteria of Multiple sclerosis in acute relapsing episodes or attacks and could be providing consent for participation in the study, will be included in the study.

Description

Inclusion Criteria:

• Any adult patient's clinical history and neuroimaging fulfilling revised McDonald diagnostic criteria of Multiple sclerosis in an acute relapsing episode or attack and could be providing consent for participation in the study, will be included in the study.

Exclusion Criteria:

• -Any patient had an infection or febrile condition.
• Any patient had other co-morbid neurological or psychiatric disorders or systemic disease or had contraindications for receiving pulse therapy (high steroid dose) or showed side effects of steroids or intolerance or seizure.
• Any patient refuses participation in the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to evaluate efficacy of a pulse therapy on clinical outcome	evaluate the efficacy of pulse therapy on pyramidal,sensory,cerebellar,brainstem,sphincter and mental by functional systems score which maximum value 46 point and least value 0	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical correlation between clinical scales scores and neurophysiological changes(visual evoked potional	visual evoked potion measured by millisecond,normal value less than 95 millisecond	after 1 day
clinical correlation between clinical scales scores and neurophysiological changes( cortical exitability parameters)	cortical exitability parameters including resting motor transmision measured by millivolt,active motor transmision measured by millivolt,cortical silent period measured by millisecond and transcallosal inhibition measured millisecond	after 1 day

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; pulse therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: multiple sclerosis and pulse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No