Lyme DiseaseLYMEPEDNCT03981874
Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children
A study testing telephonic interview in people with Lyme Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Neuroborreliosis (NB) is the second most frequent manifestation of Lyme disease. Painful meningoradiculitis is the most common neurologic manifestation in adults while facial nerve palsy (FP) and lymphocytic meningitis is predominant in children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Lyme Disease
- What is being tested?
- telephonic interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2019to 29 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children consulting for peripheral facial palsy
Who cannot join
- Children consulting for central facial palsy
- Children with congenital peripheral facial palsy
- Children with surgery and trauma in the area of the facial nerve,
- Children with peripheral facial palsy with previous diagnosis
- Children whose parents refuse the study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Peripheral Facial Paralysis Sequelae Based on the Initial Medical Care of Lyme Disease Among Children
Neuroborreliosis (NB) is the second most frequent manifestation of Lyme disease. Painful meningoradiculitis is the most common neurologic manifestation in adults while facial nerve palsy (FP) and lymphocytic meningitis is predominant in children. FP is a common reason for pediatric consultation and FP due to Lyme borreliosis (LB) represents about 50% of the child's FP in an endemic area.
The action to be taken is not formally defined for a child consulting for FP in a Lyme disease endemic area.
Read more
The new recommendations of the High Authority of Health of June 2018 recommend to carry out a blood serology in first intention, in search of a NB in a child consulting for a peripheral facial paralysis. If this is positive, a lumbar puncture will be performed in search of meningitis. In the case of negative serology, a close clinical surveillance and sometimes serological control is necessary, in order to reassess the diagnosis. In adult recommendations, a lumbar puncture is performed first in any patient consulting for facial paralysis in LB endemic area.
The main objective of this study was to describe the clinical and biological characteristics of pediatric NB with FP. Others objectives were to describe the diagnostic and therapeutic behavior of a child consulting at university hospital for a facial nerve palsy, to compare the initial gravity of facial nerve palsy, the duration of the paralysis and sequels depending on the diagnosis and treatment initiated.
- Conditions
- Lyme Disease
- Being tested
- telephonic interview
- Keywords
- neuroborreliosis, facial palsy, children
- Medical subject headings
- Lyme Disease, Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephonic interviewOther
Telephonic interview
| Study group | Role | What they receive |
|---|---|---|
| Telephonic interview | Experimental | Parents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not Receives: Other: telephonic interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of persistent sequelae
Facial paralysis duration assesment and persistence of physical sequelae at time of the telephonic call using House \& Brackmann classification for facial function.
This grading system has 6 levels, used for middle- to long-term monitoring:
- Normal II. Mild dysfunction III. Moderate dysfunction IV. Moderately severe dysfunction
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start29 May 2019
- Primary completion29 Jul 2019 (estimated)
- Study completion29 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphael Anxionnat, MD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981874
- Sponsor's protocol ID
- P/2019/419
- Acronym
- LYMEPED
- Status last verified
- Jun 2019
- First submitted
- 7 Jun 2019
- Last updated
- 12 Jun 2019
- 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 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Peripheral Facial Paralysis Sequelae Based on the Initial Medical Care of Lyme Disease Among Children
- ClinicalTrials.gov ID
- NCT03981874
- Acronym / sponsor ID
- LYMEPED / P/2019/419
- Conditions
- Lyme Disease
- Keywords
- neuroborreliosis, facial palsy, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 29 Jul 2019 (estimated)
- Study completion
- 29 Jul 2019 (estimated)
- First posted
- 11 Jun 2019 (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.
Neuroborreliosis (NB) is the second most frequent manifestation of Lyme disease. Painful meningoradiculitis is the most common neurologic manifestation in adults while facial nerve palsy (FP) and lymphocytic meningitis is predominant in children. FP is a common reason for pediatric consultation and FP due to Lyme borreliosis (LB) represents about 50% of the child's FP in an endemic area.
The action to be taken is not formally defined for a child consulting for FP in a Lyme disease endemic area.
The new recommendations of the High Authority of Health of June 2018 recommend to carry out a blood serology in first intention, in search of a NB in a child consulting for a peripheral facial paralysis. If this is positive, a lumbar puncture will be performed in search of meningitis. In the case of negative serology, a close clinical surveillance and sometimes serological control is necessary, in order to reassess the diagnosis. In adult recommendations, a lumbar puncture is performed first in any patient consulting for facial paralysis in LB endemic area.
The main objective of this study was to describe the clinical and biological characteristics of pediatric NB with FP. Others objectives were to describe the diagnostic and therapeutic behavior of a child consulting at university hospital for a facial nerve palsy, to compare the initial gravity of facial nerve palsy, the duration of the paralysis and sequels depending on the diagnosis and treatment initiated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telephonic interview | Experimental | Other: telephonic interviewParents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children consulting for peripheral facial palsy
Key exclusion criteria (5 listed)
- Children consulting for central facial palsy
- Children with congenital peripheral facial palsy
- Children with surgery and trauma in the area of the facial nerve,
- Children with peripheral facial palsy with previous diagnosis
- Children whose parents refuse the study participation
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 |
|---|---|---|
| telephonic interviewTelephonic interview | Other | Telephonic interview |
Primary outcome
Assesment of persistent sequelae
Time frame: 4 years
Facial paralysis duration assesment and persistence of physical sequelae at time of the telephonic call using House \& Brackmann classification for facial function. This grading system has 6 levels, used for middle- to long-term monitoring: I. Normal II. Mild dysfunction III. Moderate dysfunction IV. Moderately severe dysfunction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Lyme Disease
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
Lyme Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Post-treatment Lyme Disease Syndrome, Chronic Pain
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
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. This study is not recruiting at the moment.
Raphael Anxionnat, MD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephonic interview in people with Lyme Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Jun 2019. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Candice Feuillebois, Int (+33381218516, sydnak@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment of persistent sequelae (time frame: 4 years). 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 12 Jun 2019.