Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)

Study Overview
=================
Brief Summary
-----------------
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.

Official Title
-----------------
Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)

Conditions
-----------------
GBS

Intervention / Treatment
-----------------
* Device: Immunoadsorption
* Device: Plasma Exchange


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Guillain-Barré Syndrome according to the diagnostic criteria proposed by Doorn et al. (Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome, Lancet neurology 2008) age 18 years or above Exclusion Criteria: Clinical or laboratory (C-reactive protein 20 mg/l or above, or evidence of nitrite-positive urinary tract infection) evidence of manifest systemic infection Intake of angiotensin converting enzyme inhibitor within1 weeks before first treatment Other contraindications against immunoadsorption or plasma exchange

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunoadsorption<br> | Device: Immunoadsorption<br>* 1 cycle, consisting of 5 sessions on 5 consecutive days with processing of the 0.7-fold individual plasma volume (maximum 2.5 l) each days with tryptophan adsorbers.<br>|
| Plasma Exchange<br> | Device: Plasma Exchange<br>* 1 cycle, consisting of 5 sessions on 5 consecutive days with exchange of 0.7-fold plasma volume (maximum 2.5 l) each day with albumin solution as volume replacement solution.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score | Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted | 2 weeks | 
| Inflammatory Neuropathy Cause and Treatment (INCAT) disability score | Standard clinical score for inflammatory neuropathies. | 2 weeks | 
| Oxford Muscle Strength Score (Medical Research Council, MRC) | Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity). | 2 weeks | 
| Vibration Score | Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides). | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score | Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted | 1, 3, and 5 weeks | 
| Inflammatory Neuropathy Cause and Treatment (INCAT) disability score | Standard clinical score for inflammatory neuropathies. | 1, 3, and 5 weeks | 
| Oxford Muscle Strength Score (Medical Research Council, MRC) | Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity). | 1, 3, and 5 weeks | 
| Vibration Score | Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides). | 1, 3, and 5 weeks | 
| Hughes Score | Standard clinical score to quantify disability in Guillain-Barré syndrome | 1, 2, 3, and 5 weeks | 
| Pain | Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain). | 1, 2, 3, and 5 weeks | 
| N20 | N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs) | 2 and 5 weeks | 
| P40 | P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials | 2 and 5 weeks | 
| Nerve Conduction Velocity | Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG) | 2 and 5 weeks | 
| Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) | Quality of Life Scale | 1, 2, 3, and 5 weeks | 
| Immunoglobulin A in serum | Immunoglobulin A serum concentration | 1, 2, 3, and 5 weeks | 
| Immunoglobulin A in cerebrospinal fluid (CSF) | Immunoglobulin A concentration in cerebrospinal fluid | 2 weeks | 
| Immunoglobulin G in serum | Immunoglobulin G serum concentration | 1, 2, 3, and 5 weeks | 
| Immunoglobulin G in cerebrospinal fluid (CSF) | Immunoglobulin G concentration in cerebrospinal fluid | 2 weeks | 
| Immunoglobulin M in serum | Immunoglobulin M serum concentration | 1, 2, 3, and 5 weeks | 
| Immunoglobulin M in cerebrospinal fluid (CSF) | Immunoglobulin M concentration in cerebrospinal fluid | 2 weeks | 
| Interleukin-1 | Interleukin-1 serum concentration | 1, 2, 3, and 5 weeks | 
| Interleukin-6 | Interleukin-6 serum concentration | 1, 2, 3, and 5 weeks | 
| Anti-GM1 antibodies | Anti-GM1 antibody serum levels | 1, 2, 3, and 5 weeks | 
| Anti-GQ1b | Anti-GQQ1b antibody serum levels | 1, 2, 3, and 5 weeks | 
| Neurofilament light chain (NfL) serum | Neurofilament light chain (NfL) serum levels | 1, 2, 3, and 5 weeks | 
| Neurofilament light chain (NfL) in cerebrospinal fluid (CSF) | Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF) | 2 weeks | 
| Safety and Tolerability | Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 1, 2, 3, and 5 weeks | 
| Therapeutic Response | Share of patients with at least 20% improvement in CIDP score | 1, 2, 3, and 5 weeks |