IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients

April 4, 2023 updated by: Eman M. Khedr, Assiut University

IVIG Versus Plasmapheresis and Guillian Barrie Syndrome

In this study, the investigators address the question: whether treatment with IVIG is superior to treatment using plasmapheresis for functional recovery of patients with GBS? Recovery was quantified using: The changes in the A-Clinical grading scale MRC ( medial research council sum score ) and B-overall neuropathy limitations scale as the primary outcome and the changes in Neurophysiological study 3 months after treatment as a secondary outcome.

This information will be used to evaluate which treatment is more beneficial to GBS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Guillain-Barré syndrome (GBS) is an inflammatory disease of the PNS and is the most common cause of acute flaccid paralysis, with an annual global incidence of approximately 1-2 per 100,000 person-years. Patients with GBS typically present with weakness and sensory signs in the legs that progress to the arms and cranial muscles, although the clinical presentation of the disease is heterogeneous and several distinct clinical variants exist. Diagnosis of GBS is based on the patient's history and neurological, electrophysiological, and cerebrospinal fluid (CSF) examinations. Electrophysiological studies: provide evidence of peripheral nervous system (PNS) dysfunction and can distinguish between the subtypes of GBS: acute inflammatory demyelinating polyradiculoneuropathy (AIDP), acute motor axonal neuropathy (AMAN), and acute motor-sensory axonal neuropathy (AMSAN). Disease progression can be rapid, and most patients with GBS reach their maximum disability within 2 weeks. About 20% of patients with GBS develop respiratory failure and require mechanical ventilation. Cardiac arrhythmias and blood pressure instability can occur owing to the involvement of the autonomic nervous system. Immunomodulatory therapy should be started if patients are unable to walk independently for 10 m. Evidence on treatment efficacy in patients who can still walk independently is limited, but treatment should be considered, especially if these patients display rapidly progressive weakness or other severe symptoms such as autonomic dysfunction, bulbar failure, or respiratory insufficiency. Clinical trials have demonstrated a treatment effect for intravenous immunoglobulin (IVIg) when started within 2 weeks of the onset of weakness and for plasma exchange when started within 4 weeks.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-70 years old,
  • Onset: Recent onset of GBS through the first 2 weeks.
  • Gender: Male or Female Inclusion Criteria.

Exclusion Criteria:

  • patients with metabolic disorders, or malignancy,
  • other causes of peripheral neuropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 plasmapheresis
Arm 1 (plasmapheresis): This study will be conducted at Assiut University at Neurology and psychiatry department as Group 1 of patients presented with Guillian Barrie syndrome (54 patients) will be subjected to plasmapheresis after assessment of clinical state and scales including MRC, Erasmus Guillain-Barre respiratory insufficiency score and Overall neuropathy limitation scale and Neurophysiological studies. Each patient was evaluated at baseline and at Follow up assessment points (one month and 3 months, one year follow up)
Device: plasmapheresis device
Group 1: 54 patients of Guillian Barrie syndrome undergo plasma exchange (5 sessions)
Other Names:
  • plasma exchange device
Active Comparator: Arm 2: Intravenous injection of immunoglobulin
This study will be conducted at Assiut University at Neurology and psychiatry department as Group 2 of patients presented with Guillian Barrie syndrome (27 patients) will be subjected to intravenous injection of immunoglobulin after assessment of clinical state and scales including MRC, Erasmus Guillain-Barre respiratory insufficiency score, and Overall neuropathy limitation scale and Neurophysiological studies. Each patient was evaluated at baseline and at Follow up assessment points (one month and 3 months, one year follow up).
Drug: Intravenous immunoglobulin
group 2: 27 patients undergo intravenous injection of immunoglobulin for 5 consecutive days of IVIG 0.4gm/kg/day.
Other Names:
  • IVIG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical grading scale MRC ( medial research council sum score )
Time Frame: the points change from baseline scale and after 3 months follow up
Clinical grading scale MRC ( medial research council sum score ) from zero ( no power ) up to 60 full power (points): sum score of muscle power in both upper limbs and lower limbs in points .
the points change from baseline scale and after 3 months follow up
Overall neuropathy limitations scale (ONLS) .
Time Frame: the changes in points from baseline assessment score to 3 months follow up assessment score.
it is modified disability sum score: sum of arm grade and leg grade limitation score; arm grade from zero point ( less limitation ) to 5 points ( most limitation ) and leg grade from zero point ( less limitation) to 7 points (more limitation)
the changes in points from baseline assessment score to 3 months follow up assessment score.
ERASMUS GBS respiratory insufficiency score EGRIS
Time Frame: the change in points from baseline assessment score to 3 months follow up assessment score.
Predict the probability of respiratory insufficiency within the first week of admission, in individual patients with Guillain-Barre. syndrome from zero to 7 points score : 0 point ( no affection ) , 7 point ( severe affection )
the change in points from baseline assessment score to 3 months follow up assessment score.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurophysiological study: Distal latency in mill second, Nerve conduction velocities in Meter/second, and F-wave latency mill second
Time Frame: the change in points from baseline assessment score to 3 months follow up assessment score.
Neurophysiological study neurophysiological study pre- and after 3 months change of degree of affection and improvement in latency in nerve conduction m/ sec. amplitude m/v , velocity of nerve /s conduction and F-wave of both upper limbs and lower limbs
the change in points from baseline assessment score to 3 months follow up assessment score.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

March 2, 2022

Study Completion (Actual)

March 3, 2023

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Guillian Barrie syndrome

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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