Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280131
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-09
Brief Title:
The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients Clinical and Neurophysiology Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Multiple sclerosis MS is an inflammatory demyelinating disease of the Central Nervous System CNS with a variety of clinical presentations MS affects 25 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 gday for 3-5 days is given often followed by an oral course of prednisone beginning at a dose of 60-80 mgday 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 didnt 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 TCIand 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 electrophysiologicalboth 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
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 gday for 3-5 days is given often followed by an oral course of prednisone beginning at a dose of 60-80 mgday 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 didnt 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 TCIand 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 electrophysiologicalboth 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None