Guillain Barré SyndromeNCT06615622
Our Study Aims to Determine if Nerve Alterations in Acute GBS and CIDP Detectable by Ultrasound Match Electrodiagnostic Findings and if This Method Aids Early Diagnosis, Predict Their Outcomes and Differentiate Between Axonal and Demyelinating Subtypes.
An observational study of Guillain Barré Syndrome and Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Assiut University at 1 site in Egypt.
Trial summary
Neuromuscular ultrasound (NMUS) is emerging as a valuable non-invasive diagnostic tool. In GBS, NMUS can detect proximal nerve enlargement early, before neurophysiological changes. Persistent nerve enlargement can be observed up to 15 years, though its correlation with disability varies. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Guillain Barré Syndrome, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Peripheral Nerve Disorder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 30 Mar 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A hospital-based study. Patients who are admitted to Assiut university hospitals, neuropsychiatry department.
Who may be able to join
- Diagnosis of patient group:
- GBS Patients: Diagnosed according to the criteria of the National Institute of Neurological Disorders and Stroke (NINDS) and the Brighton Collaboration (2011).
- CIDP Patients: Diagnosed according to the criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS).
- Age: Participants aged 18 to 75 years.
- Onset:
- GBS Patients: Recent onset of GBS within the first 2 weeks of symptom onset.
Show all 10Show fewer
- CIDP Patients: Either relapsing or progressive course consistent with CIDP diagnosis.
- Gender: Both male and female participants are eligible.
- Participation: Willingness to participate in the study, including undergoing disease-related examinations and assessments.
- Consent: Ability and willingness to provide informed consent
Who cannot join
- Patients unable or unwilling to provide informed consent.
- Patients with metabolic disorders or malignancies.
- Patients with other causes of peripheral neuropathy.
- Patients with other causes of acute flaccid paralysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospitals
Asyut
Vice president of graduate studies of Assiut University, +2088 22080150, vp_grad@aun.edu.eg
About this study
Official title: A Comparative Study of Peripheral Nerve Ultrasound Findings in Immune Mediated Peripheral Nerve Disorders; a Hospital-based Study
Neuromuscular ultrasound (NMUS) is emerging as a valuable non-invasive diagnostic tool. In GBS, NMUS can detect proximal nerve enlargement early, before neurophysiological changes. Persistent nerve enlargement can be observed up to 15 years, though its correlation with disability varies. Research is needed to clarify NMUS findings in GBS and CIDP over time. Early detection of nerve root enlargement via NMUS could facilitate earlier diagnosis and intervention, improving patient outcomes and understanding of these conditions\' pathophysiology.
This study aims to determine if nerve alterations in acute GBS and CIDP detectable by ultrasound match electrodiagnostic findings and if this method aids early diagnosis. The investigators will perform serial nerve ultrasounds and NCS to investigate nerve morphology, predict outcomes, and differentiate between axonal and demyelinating subtypes.
- Conditions
- Guillain Barré Syndrome, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Peripheral Nerve Disorder, Peripheral Nerves US, Peripheral Neuropathy
- Being tested
- Placebo
- Keywords
- Peripheral nerve ultrasound, immune mediated nerve disorders, Guillain-Barré syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy
- Medical subject headings
- Guillain-Barre Syndrome, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Neuritis, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Thiotacid 300 mg tab once/day
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with immune mediated peripheral nerve disorders GB syndrome and CIDP Receives: Dietary Supplement: Placebo | |
| Control | Healthy control matching group Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Nerve Alterations via Ultrasound
- Determine if patients with acute GBS and CIDP exhibit nerve alterations detectable by ultrasound that are comparable to electrodiagnostic findings.
- Assess the utility of ultrasound in diagnosing GBS and CIDP in the very early phase of the disease.
Measured: 6 months
Secondary outcomes (5)
Evaluation of Nerve Morphology Evolution
- Investigate patterns of nerve morphology through nerve ultrasound studies in GBS and CIDP patients over the course of the disease.
- Compare these patterns with serial NCS findings.
Measured: 6 months
Prediction of Outcomes and Recovery
- Evaluate the potential of nerve ultrasound changes as predictors of clinical outcomes and recovery in GBS and CIDP patients.
Measured: 6 months
Differentiation of Subtypes
- Assess if early nerve ultrasound changes can differentiate between axonal and demyelinating subtypes of GBS and CIDP.
Measured: 6 months
Correlation with Clinical Scales
- Correlate ultrasound findings with clinical scales and outcomes, such as the Guillain-Barré Syndrome Disability Scale (GDS), Medical Research Council Sum Score (MRC sum score), and Erasmus GBS Outcome Scale (EGOS)
Measured: 6 months
Comparison with Healthy Controls
- Compare the ultrasound parameters of GBS and CIDP patients with age and sex-matched healthy controls to identify significant differences in nerve morphology
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Sep 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Guillain Barré SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Gad Ibrahim Farghly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615622
- Sponsor's protocol ID
- 04-2024-200877
- Status last verified
- Oct 2025
- First submitted
- 19 Sep 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hughes RA, Swan AV, Raphael JC, Annane D, van Koningsveld R, van Doorn PA. Immunotherapy for Guillain-Barre syndrome: a systematic review. Brain. 2007 Sep;130(Pt 9):2245-57. doi: 10.1093/brain/awm004. Epub 2007 Mar 2.
PubMed 17337484Hughes RA, Raphael JC, Swan AV, Doorn PA. Intravenous immunoglobulin for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2004;(1):CD002063. doi: 10.1002/14651858.CD002063.pub2.
PubMed 14973982Hughes RA, Swan AV, van Doorn PA. Intravenous immunoglobulin for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2014 Sep 19;2014(9):CD002063. doi: 10.1002/14651858.CD002063.pub6.
PubMed 25238327van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barre syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15.
PubMed 25023340Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barre syndrome. Lancet. 2016 Aug 13;388(10045):717-27. doi: 10.1016/S0140-6736(16)00339-1. Epub 2016 Mar 2.
PubMed 26948435Jacobs BC, Rothbarth PH, van der Meche FG, Herbrink P, Schmitz PI, de Klerk MA, van Doorn PA. The spectrum of antecedent infections in Guillain-Barre syndrome: a case-control study. Neurology. 1998 Oct;51(4):1110-5. doi: 10.1212/wnl.51.4.1110.
PubMed 9781538Laman JD, Huizinga R, Boons GJ, Jacobs BC. Guillain-Barre syndrome: expanding the concept of molecular mimicry. Trends Immunol. 2022 Apr;43(4):296-308. doi: 10.1016/j.it.2022.02.003. Epub 2022 Mar 4.
PubMed 35256276Sejvar JJ, Baughman AL, Wise M, Morgan OW. Population incidence of Guillain-Barre syndrome: a systematic review and meta-analysis. Neuroepidemiology. 2011;36(2):123-33. doi: 10.1159/000324710. Epub 2011 Mar 21.
PubMed 21422765
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Peripheral Nerve Ultrasound Findings in Immune Mediated Peripheral Nerve Disorders; a Hospital-based Study
- ClinicalTrials.gov ID
- NCT06615622
- Acronym / sponsor ID
- 04-2024-200877
- Conditions
- Guillain Barré Syndrome, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Peripheral Nerve Disorder, Peripheral Nerves US, Peripheral Neuropathy
- Keywords
- Peripheral nerve ultrasound, immune mediated nerve disorders, Guillain-Barré syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuromuscular ultrasound (NMUS) is emerging as a valuable non-invasive diagnostic tool. In GBS, NMUS can detect proximal nerve enlargement early, before neurophysiological changes. Persistent nerve enlargement can be observed up to 15 years, though its correlation with disability varies. Research is needed to clarify NMUS findings in GBS and CIDP over time. Early detection of nerve root enlargement via NMUS could facilitate earlier diagnosis and intervention, improving patient outcomes and understanding of these conditions\' pathophysiology.
This study aims to determine if nerve alterations in acute GBS and CIDP detectable by ultrasound match electrodiagnostic findings and if this method aids early diagnosis. The investigators will perform serial nerve ultrasounds and NCS to investigate nerve morphology, predict outcomes, and differentiate between axonal and demyelinating subtypes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Dietary Supplement: PlaceboPatients with immune mediated peripheral nerve disorders GB syndrome and CIDP |
| Control | – | Dietary Supplement: PlaceboHealthy control matching group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A hospital-based study. Patients who are admitted to Assiut university hospitals, neuropsychiatry department.
Key inclusion criteria (10 listed)
- Diagnosis of patient group:
- Age: Participants aged 18 to 75 years.
- Onset:
- Gender: Both male and female participants are eligible.
- Participation: Willingness to participate in the study, including undergoing disease-related examinations and assessments.
Key exclusion criteria (4 listed)
- Patients unable or unwilling to provide informed consent.
- Patients with metabolic disorders or malignancies.
- Patients with other causes of peripheral neuropathy.
- Patients with other causes of acute flaccid paralysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThiotacid 300 mg tab once/day | Dietary supplement | Case, Control |
Primary outcome
Detection of Nerve Alterations via Ultrasound
Time frame: 6 months
* Determine if patients with acute GBS and CIDP exhibit nerve alterations detectable by ultrasound that are comparable to electrodiagnostic findings. * Assess the utility of ultrasound in diagnosing GBS and CIDP in the very early phase of the disease.
5 secondary outcomes
Evaluation of Nerve Morphology Evolution
Time frame: 6 months
Prediction of Outcomes and Recovery
Time frame: 6 months
Differentiation of Subtypes
Time frame: 6 months
Correlation with Clinical Scales
Time frame: 6 months
Comparison with Healthy Controls
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 17337484Hughes RA, Swan AV, Raphael JC, Annane D, van Koningsveld R, van Doorn PA. Immunotherapy for Guillain-Barre syndrome: a systematic review. Brain. 2007 Sep;130(Pt 9):2245-57. doi: 10.1093/brain/awm004. Epub 2007 Mar 2.
- Background: PubMed 14973982Hughes RA, Raphael JC, Swan AV, Doorn PA. Intravenous immunoglobulin for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2004;(1):CD002063. doi: 10.1002/14651858.CD002063.pub2.
- Background: PubMed 25238327Hughes RA, Swan AV, van Doorn PA. Intravenous immunoglobulin for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2014 Sep 19;2014(9):CD002063. doi: 10.1002/14651858.CD002063.pub6.
- Background: PubMed 25023340van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barre syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15.
- Background: PubMed 26948435Willison HJ, Jacobs BC, van Doorn PA. Guillain-Barre syndrome. Lancet. 2016 Aug 13;388(10045):717-27. doi: 10.1016/S0140-6736(16)00339-1. Epub 2016 Mar 2.
- Background: PubMed 9781538Jacobs BC, Rothbarth PH, van der Meche FG, Herbrink P, Schmitz PI, de Klerk MA, van Doorn PA. The spectrum of antecedent infections in Guillain-Barre syndrome: a case-control study. Neurology. 1998 Oct;51(4):1110-5. doi: 10.1212/wnl.51.4.1110.
- Background: PubMed 35256276Laman JD, Huizinga R, Boons GJ, Jacobs BC. Guillain-Barre syndrome: expanding the concept of molecular mimicry. Trends Immunol. 2022 Apr;43(4):296-308. doi: 10.1016/j.it.2022.02.003. Epub 2022 Mar 4.
- Background: PubMed 21422765Sejvar JJ, Baughman AL, Wise M, Morgan OW. Population incidence of Guillain-Barre syndrome: a systematic review and meta-analysis. Neuroepidemiology. 2011;36(2):123-33. doi: 10.1159/000324710. Epub 2011 Mar 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Guillain Barré Syndrome and Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Gad Ibrahim, MB, BCh (+201022748859 ext. 1022748859, modyurd222@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Nerve Alterations via Ultrasound (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06615622, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.