Multiple SclerosisNCT06280131
The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients:
An observational study of Multiple Sclerosis, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Apr 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -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.
Trial locations and contacts
No sites are listed yet.
Noha M Abo-Elfetoh, PHD contact
About this study
Official title: 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
Read the 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, pulse therapy
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (2)
clinical correlation between clinical scales scores and neurophysiological changes(visual evoked potional
visual evoked potion measured by millisecond,normal value less than 95 millisecond
Measured: 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
Measured: after 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Entsar Karem Abd Elazeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280131
- Sponsor's protocol ID
- multiple sclerosis and pulse
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients: Clinical and Neurophysiology Study.
- ClinicalTrials.gov ID
- NCT06280131
- Acronym / sponsor ID
- multiple sclerosis and pulse
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, pulse therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to evaluate efficacy of a pulse therapy on clinical outcome
Time frame: 1 month
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
2 secondary outcomes
clinical correlation between clinical scales scores and neurophysiological changes(visual evoked potional
Time frame: after 1 day
clinical correlation between clinical scales scores and neurophysiological changes( cortical exitability parameters)
Time frame: after 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha M Abo-Elfetoh, PHD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Entsar karem, resident (0201030698902, entsarkarem07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate efficacy of a pulse therapy on clinical outcome (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.