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

NCT06280131 | Not Yet Recruiting

• 1 other identifier: multiple sclerosis and pulse
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; pulse therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• clinical correlation between clinical scales scores and neurophysiological changes(visual evoked potional

  after 1 day

• clinical correlation between clinical scales scores and neurophysiological changes( cortical exitability parameters)

  after 1 day

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Entsar karem, resident

CONTACT

0201030698902; entsarkarem07@gmail.com

Noha M Abo-Elfetoh, PHD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL