Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
- Conditions
- GBS
- Interventions
- Device: ImmunoadsorptionDevice: Plasma Exchange
- Registration Number
- NCT04871035
- Lead Sponsor
- University of Ulm
- Brief Summary
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Immunoadsorption Immunoadsorption - Plasma Exchange Plasma Exchange -
- Primary Outcome Measures
Name Time Method Inflammatory Neuropathy Cause and Treatment (INCAT) disability score 2 weeks Standard clinical score for inflammatory neuropathies.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score 2 weeks Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted
Oxford Muscle Strength Score (Medical Research Council, MRC) 2 weeks 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).
Vibration Score 2 weeks 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).
- Secondary Outcome Measures
Name Time Method Interleukin-6 1, 2, 3, and 5 weeks Interleukin-6 serum concentration
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score 1, 3, and 5 weeks Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score 1, 3, and 5 weeks Standard clinical score for inflammatory neuropathies.
Vibration Score 1, 3, and 5 weeks 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).
Hughes Score 1, 2, 3, and 5 weeks Standard clinical score to quantify disability in Guillain-Barré syndrome
Nerve Conduction Velocity 2 and 5 weeks Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG)
Immunoglobulin A in cerebrospinal fluid (CSF) 2 weeks Immunoglobulin A concentration in cerebrospinal fluid
Interleukin-1 1, 2, 3, and 5 weeks Interleukin-1 serum concentration
Neurofilament light chain (NfL) in cerebrospinal fluid (CSF) 2 weeks Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF)
Pain 1, 2, 3, and 5 weeks Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain).
Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) 1, 2, 3, and 5 weeks Quality of Life Scale
Immunoglobulin G in serum 1, 2, 3, and 5 weeks Immunoglobulin G serum concentration
Anti-GQ1b 1, 2, 3, and 5 weeks Anti-GQQ1b antibody serum levels
Oxford Muscle Strength Score (Medical Research Council, MRC) 1, 3, and 5 weeks 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).
N20 2 and 5 weeks N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs)
Immunoglobulin A in serum 1, 2, 3, and 5 weeks Immunoglobulin A serum concentration
Immunoglobulin M in serum 1, 2, 3, and 5 weeks Immunoglobulin M serum concentration
Anti-GM1 antibodies 1, 2, 3, and 5 weeks Anti-GM1 antibody serum levels
Immunoglobulin G in cerebrospinal fluid (CSF) 2 weeks Immunoglobulin G concentration in cerebrospinal fluid
Immunoglobulin M in cerebrospinal fluid (CSF) 2 weeks Immunoglobulin M concentration in cerebrospinal fluid
Neurofilament light chain (NfL) serum 1, 2, 3, and 5 weeks Neurofilament light chain (NfL) serum levels
Safety and Tolerability 1, 2, 3, and 5 weeks Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Therapeutic Response 1, 2, 3, and 5 weeks Share of patients with at least 20% improvement in CIDP score
P40 2 and 5 weeks P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials
Trial Locations
- Locations (1)
Department of Neurology, University of Ulm
🇩🇪Ulm, Baden-Württemberg, Germany