Guillain Barré SyndromeGUIREQUALNCT06940908
Living With Guillain-Barré Syndrome as Children.
An observational study of Guillain Barré Syndrome and Guillain-Barré Syndrome (GBS), run by University Hospital, Toulouse at 2 sites in France.
Trial summary
The goal of this qualitative observational study is to explore the lived experience and psychological aftermath of children who were affected by Guillain-Barré Syndrome (GBS) two to five years earlier. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Guillain Barré Syndrome, Guillain-Barré Syndrome (GBS)
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- 5 May 2025to 1 Jun 2027
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be selected from the population of children and adolescents who experienced Guillain-Barré Syndrome (GBS) during childhood and received medical care at one of two university hospitals in southern France: Toulouse University Hospital and Montpellier University Hospital. Eligible participants will be aged 10 years or older at the time of the study and must be between 2 and 5 years post-acute GBS episode. The population includes individuals with sufficient command of the French language to engage in a semi-structured interview exploring the long-term psychosocial impact of GBS. Both male and female participants will be considered, provided they meet the inclusion criteria and give informed consent (or assent with parental consent for minors).
Who may be able to join
- Children or adolescents aged 10 years or older at the time of the interview
- History of Guillain-Barré syndrome (GBS) diagnosed in childhood
- Time since acute episode: between 2 and 5 years
- Sufficient mastery of the French language to participate in a semi-structured interview
- Consent of the participant and, for minors, parental consent
Who cannot join
- Presence of a neurological disease other than GBS that may interfere with participation or interpretation of data
- Severe cognitive impairment preventing the child or adolescent from engaging in the interview
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
University Hospital of Montpellier
Montpellier, Occitanie, 34295
Pierre MEYER, MD, 04 67 33 01 82, p-meyer@chu-montpellier.fr
Juliette thorel, md resident, thorel.j@chu-toulouse.fr
- Recruiting
University Hospital Toulouse
Toulouse, Occitanie, 31059
bastien estublier, MD, 0561777087, lebervet.c@chu-toulouse.fr
Juliette thorel, md resident, 335 34 55 85 75, thorel.j@chu-toulouse.fr
About this study
Official title: Experience of Guillain Barré Syndrome in Childhood: A French Multicentric Qualitative Study
The goal of this qualitative observational study is to explore the lived experience and psychological aftermath of children who were affected by Guillain-Barré Syndrome (GBS) two to five years earlier. GBS is a rare and acute neurological condition, and while motor recovery is generally good in children, residual symptoms such as fatigue, pain, anxiety, or depression may persist and impact quality of life.
The main questions it aims to answer are:
Read more
How do children experience and recall their illness and recovery after GBS? What psychological or contextual factors might contribute to emotional distress or depressive symptoms in the years following the disease?
Participants will:
Be children aged 10 or older who had GBS two to five years prior. Participate in a 45-60-minute semi-structured individual interview during a routine follow-up visit.
Respond to a screening questionnaire for depressive symptoms (Children's Depression Inventory or Beck Depression Inventory Fast Screen).
Undergo a brief clinical examination to assess any remaining physical sequelae. Interviews will be audio recorded, transcribed verbatim, and pseudonymized. Thematic reflexive analysis will be performed following Braun and Clarke's methodology. Recruitment will continue until theoretical saturation is reached (approximately 25 participants expected) across two centers (Toulouse and Montpellier).
This study aims to generate new insights into pediatric psychological outcomes after GBS, in order to improve acute care and follow-up, and potentially guide future mental health support for affected children.
Read the detailed description
Guillain-Barré Syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy that can lead to significant functional impairment. Although pediatric patients typically experience more favorable motor recovery compared to adults, emerging clinical observations suggest that psychological and sensory sequelae-such as fatigue, neuropathic pain, paresthesia, anxiety disorders, and major depressive episodes-may persist long after the acute phase.
To date, no qualitative research has specifically examined how children experience GBS and its aftermath, particularly years after recovery. The GUIREQUAL study is designed to fill this gap by using qualitative methods to explore long-term psychosocial impacts among pediatric GBS survivors, and to develop hypotheses regarding psychological vulnerability post-recovery.
This is a bicentric, prospective qualitative study conducted in two pediatric neurology centers (Toulouse and Montpellier, France). Participants will be identified from hospital records and must meet strict inclusion criteria, including a confirmed diagnosis of GBS or its variants (AIDP, AMAN, Miller Fisher), with onset 2 to 5 years prior to study enrollment. Patients with chronic inflammatory demyelinating polyneuropathy (CIDP), central nervous system involvement (e.g., Bickerstaff encephalitis), or unrelated chronic neurological/orthopedic diseases will be excluded to reduce confounding factors.
The data collection process includes:
A semi-structured, face-to-face interview (45-60 minutes) conducted during a routine follow-up visit, allowing the child (with or without parental presence, depending on age) to recount their illness experience in a supportive setting.
A brief validated screening tool to assess current depressive symptoms (CDI or BDI-FS).
A short clinical assessment by an independent clinician to evaluate any remaining physical sequelae.
Interviews will be audio-recorded, transcribed verbatim, and pseudonymized for confidentiality. Thematic reflexive analysis will be conducted following the Braun \& Clarke methodology. Transcripts will be coded iteratively, and themes will be developed inductively and refined throughout the study process, in accordance with qualitative research best practices. Data collection will continue until theoretical saturation is achieved (estimated at 25 participants), ensuring the robustness of thematic conclusions.
The research team will maintain a reflexive logbook to track methodological decisions, and triangulation will be employed across multiple researchers to enhance credibility. This approach is expected to yield a nuanced understanding of how children make sense of their illness experience and what psychosocial factors may contribute to long-term well-being or distress.
Ultimately, GUIREQUAL aims to generate new clinical hypotheses, inform psychosocial follow-up strategies, and potentially advocate for early mental health screening and support in pediatric GBS survivors.
- Keywords
- children, experience, qualitative study, quality of life
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| semi-structured interview | There are no intervention or comparison groups, as this is a non-interventional qualitative study. All participants will undergo a single semi-structured interview, conducted in a child-friendly and supportive setting (either in person at the hospital, or via secure video conferencing when necessary). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's psychological and emotional experience after Guillain-Barré Syndrome
The child's subjective experience will be assessed through a semi-structured individual interview conducted by a trained researcher. The outcome will explore psychological themes such as fear, anxiety, mood changes, body image, and coping strategies in the aftermath of Guillain-Barré Syndrome. Interviews will be recorded, transcribed verbatim, and analyzed using inductive thematic analysis. No standardized questionnaire will be used; the approach is entirely qualitative and descriptive.
Measured: From 6 months to 5 years after the acute Guillain-Barré episode
Secondary outcomes (1)
Child's perception of hospitalization and medical care during Guillain-Barré Syndrome
This outcome will assess how the child perceived their stay in hospital during the acute phase of Guillain-Barré Syndrome, including memories of medical procedures, communication with healthcare professionals, perceived support, and emotional reactions. Information will be gathered through semi-structured interviews, allowing the participant to freely express their lived experience. Thematic content analysis will be used to identify recurring patterns and significant narratives. Retrospective exploration from the onset of symptoms through hospital discharge.
Measured: From 6 months to 5 years after the acute Guillain-Barré episode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start5 May 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain Barré SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940908
- Sponsor's protocol ID
- RC31/24/0615
- Acronym
- GUIREQUAL
- Status last verified
- May 2026
- First submitted
- 15 Apr 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of Guillain Barré Syndrome in Childhood: A French Multicentric Qualitative Study
- ClinicalTrials.gov ID
- NCT06940908
- Acronym / sponsor ID
- GUIREQUAL / RC31/24/0615
- Keywords
- children, experience, qualitative study, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 23 Apr 2025 (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.
The goal of this qualitative observational study is to explore the lived experience and psychological aftermath of children who were affected by Guillain-Barré Syndrome (GBS) two to five years earlier. GBS is a rare and acute neurological condition, and while motor recovery is generally good in children, residual symptoms such as fatigue, pain, anxiety, or depression may persist and impact quality of life.
The main questions it aims to answer are:
How do children experience and recall their illness and recovery after GBS? What psychological or contextual factors might contribute to emotional distress or depressive symptoms in the years following the disease?
Participants will:
Be children aged 10 or older who had GBS two to five years prior. Participate in a 45-60-minute semi-structured individual interview during a routine follow-up visit.
Respond to a screening questionnaire for depressive symptoms (Children's Depression Inventory or Beck Depression Inventory Fast Screen).
Undergo a brief clinical examination to assess any remaining physical sequelae. Interviews will be audio recorded, transcribed verbatim, and pseudonymized. Thematic reflexive analysis will be performed following Braun and Clarke's methodology. Recruitment will continue until theoretical saturation is reached (approximately 25 participants expected) across two centers (Toulouse and Montpellier).
This study aims to generate new insights into pediatric psychological outcomes after GBS, in order to improve acute care and follow-up, and potentially guide future mental health support for affected children.
Detailed description
Guillain-Barré Syndrome (GBS) is an acute inflammatory demyelinating polyneuropathy that can lead to significant functional impairment. Although pediatric patients typically experience more favorable motor recovery compared to adults, emerging clinical observations suggest that psychological and sensory sequelae-such as fatigue, neuropathic pain, paresthesia, anxiety disorders, and major depressive episodes-may persist long after the acute phase.
To date, no qualitative research has specifically examined how children experience GBS and its aftermath, particularly years after recovery. The GUIREQUAL study is designed to fill this gap by using qualitative methods to explore long-term psychosocial impacts among pediatric GBS survivors, and to develop hypotheses regarding psychological vulnerability post-recovery.
This is a bicentric, prospective qualitative study conducted in two pediatric neurology centers (Toulouse and Montpellier, France). Participants will be identified from hospital records and must meet strict inclusion criteria, including a confirmed diagnosis of GBS or its variants (AIDP, AMAN, Miller Fisher), with onset 2 to 5 years prior to study enrollment. Patients with chronic inflammatory demyelinating polyneuropathy (CIDP), central nervous system involvement (e.g., Bickerstaff encephalitis), or unrelated chronic neurological/orthopedic diseases will be excluded to reduce confounding factors.
The data collection process includes:
A semi-structured, face-to-face interview (45-60 minutes) conducted during a routine follow-up visit, allowing the child (with or without parental presence, depending on age) to recount their illness experience in a supportive setting.
A brief validated screening tool to assess current depressive symptoms (CDI or BDI-FS).
A short clinical assessment by an independent clinician to evaluate any remaining physical sequelae.
Interviews will be audio-recorded, transcribed verbatim, and pseudonymized for confidentiality. Thematic reflexive analysis will be conducted following the Braun \& Clarke methodology. Transcripts will be coded iteratively, and themes will be developed inductively and refined throughout the study process, in accordance with qualitative research best practices. Data collection will continue until theoretical saturation is achieved (estimated at 25 participants), ensuring the robustness of thematic conclusions.
The research team will maintain a reflexive logbook to track methodological decisions, and triangulation will be employed across multiple researchers to enhance credibility. This approach is expected to yield a nuanced understanding of how children make sense of their illness experience and what psychosocial factors may contribute to long-term well-being or distress.
Ultimately, GUIREQUAL aims to generate new clinical hypotheses, inform psychosocial follow-up strategies, and potentially advocate for early mental health screening and support in pediatric GBS survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| semi-structured interview | – | –There are no intervention or comparison groups, as this is a non-interventional qualitative study. All participants will undergo a single semi-structured interview, conducted in a child-friendly and supportive setting (either in person at the hospital, or via secure video conferencing when necessary). |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be selected from the population of children and adolescents who experienced Guillain-Barré Syndrome (GBS) during childhood and received medical care at one of two university hospitals in southern France: Toulouse University Hospital and Montpellier University Hospital. Eligible participants will be aged 10 years or older at the time of the study and must be between 2 and 5 years post-acute GBS episode. The population includes individuals with sufficient command of the French language to engage in a semi-structured interview exploring the long-term psychosocial impact of GBS. Both male and female participants will be considered, provided they meet the inclusion criteria and give informed consent (or assent with parental consent for minors).
Key inclusion criteria (5 listed)
- Children or adolescents aged 10 years or older at the time of the interview
- History of Guillain-Barré syndrome (GBS) diagnosed in childhood
- Time since acute episode: between 2 and 5 years
- Sufficient mastery of the French language to participate in a semi-structured interview
- Consent of the participant and, for minors, parental consent
Key exclusion criteria (2 listed)
- Presence of a neurological disease other than GBS that may interfere with participation or interpretation of data
- Severe cognitive impairment preventing the child or adolescent from engaging in the interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child's psychological and emotional experience after Guillain-Barré Syndrome
Time frame: From 6 months to 5 years after the acute Guillain-Barré episode
The child's subjective experience will be assessed through a semi-structured individual interview conducted by a trained researcher. The outcome will explore psychological themes such as fear, anxiety, mood changes, body image, and coping strategies in the aftermath of Guillain-Barré Syndrome. Interviews will be recorded, transcribed verbatim, and analyzed using inductive thematic analysis. No standardized questionnaire will be used; the approach is entirely qualitative and descriptive.
1 secondary outcome
Child's perception of hospitalization and medical care during Guillain-Barré Syndrome
Time frame: From 6 months to 5 years after the acute Guillain-Barré episode
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 8 May 2026.
- Individual participant dataSharing planned: No
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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.
2 sites 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 Guillain-Barré Syndrome (GBS), run by University Hospital, Toulouse at 2 sites in France.
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 5 inclusion and 2 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Bastien ESTUBLIER, MD (33 5 34 55 85 75, estublier.b@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's psychological and emotional experience after Guillain-Barré Syndrome (time frame: From 6 months to 5 years after the acute Guillain-Barré episode). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.