An observational study in GBS, sponsored by University of Ulm. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Ulm · Observational
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.
University of Ulm is the lead sponsor of 143 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of patients diagnosed with Guillain-Barré syndrome (GBS) who are treated with either plasma exchange or immunoadsorption in the Department of Neurology, University of Ulm.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Immunoadsorption
Device: Plasma Exchange
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.
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.
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
Time frame: 2 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
Standard clinical score for inflammatory neuropathies.
Time frame: 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).
Time frame: 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).
Time frame: 2 weeks
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
Time frame: 1, 3, and 5 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
Standard clinical score for inflammatory neuropathies.
Time frame: 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).
Time frame: 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).
Time frame: 1, 3, and 5 weeks
Hughes Score
Standard clinical score to quantify disability in Guillain-Barré syndrome
Time frame: 1, 2, 3, and 5 weeks
Pain
Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain).
Time frame: 1, 2, 3, and 5 weeks
N20
N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs)
Time frame: 2 and 5 weeks
P40
P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials
Time frame: 2 and 5 weeks
Nerve Conduction Velocity
Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG)
Time frame: 2 and 5 weeks
Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
Quality of Life Scale
Time frame: 1, 2, 3, and 5 weeks
Immunoglobulin A in serum
Immunoglobulin A serum concentration
Time frame: 1, 2, 3, and 5 weeks
Immunoglobulin A in cerebrospinal fluid (CSF)
Immunoglobulin A concentration in cerebrospinal fluid
Time frame: 2 weeks
Immunoglobulin G in serum
Immunoglobulin G serum concentration
Time frame: 1, 2, 3, and 5 weeks
Immunoglobulin G in cerebrospinal fluid (CSF)
Immunoglobulin G concentration in cerebrospinal fluid
Time frame: 2 weeks
Immunoglobulin M in serum
Immunoglobulin M serum concentration
Time frame: 1, 2, 3, and 5 weeks
Immunoglobulin M in cerebrospinal fluid (CSF)
Immunoglobulin M concentration in cerebrospinal fluid
Time frame: 2 weeks
Interleukin-1
Interleukin-1 serum concentration
Time frame: 1, 2, 3, and 5 weeks
Interleukin-6
Interleukin-6 serum concentration
Time frame: 1, 2, 3, and 5 weeks
Anti-GM1 antibodies
Anti-GM1 antibody serum levels
Time frame: 1, 2, 3, and 5 weeks
Anti-GQ1b
Anti-GQQ1b antibody serum levels
Time frame: 1, 2, 3, and 5 weeks
Neurofilament light chain (NfL) serum
Neurofilament light chain (NfL) serum levels
Time frame: 1, 2, 3, and 5 weeks
Neurofilament light chain (NfL) in cerebrospinal fluid (CSF)
Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF)
Time frame: 2 weeks
Safety and Tolerability
Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 1, 2, 3, and 5 weeks
Therapeutic Response
Share of patients with at least 20% improvement in CIDP score
Time frame: 1, 2, 3, and 5 weeks
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.
Supporting information: Study protocol
Time frame: 3 months after publication until 5 years after publication
Access criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal.
Data sharing details ↗ · www.uniklinik-ulm.de
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for Sep 2027, 76 months after the start.
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