Skip to main content
OpenTrials
Completed

NCT Number: NCT05104762

IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

plasmapheresis device

Device

Group 1: 54 patients of Guillian Barrie syndrome undergo plasma exchange (5 sessions)

Other names: plasma exchange device

intravenous immunoglobulin

Drug

group 2: 27 patients undergo intravenous injection of immunoglobulin for 5 consecutive days of IVIG 0.4gm/kg/day.

Other names: IVIG

Primary outcomes

  1. 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 .

  2. 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)

  3. 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 )

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

IVIG Versus Plasmapheresis and Guillian Barrie Syndrome

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Nov 3, 2021
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.