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Status unknownNCT03981874LYMEPEDUpdated Jun 12, 2019

Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children

An interventional study of telephonic interview in Lyme Disease, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2019-06-12.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Lyme Disease

Keywords

  • neuroborreliosis
  • facial palsy
  • children
03

In context

Lyme Disease

91 studies on the registry are indexed under Lyme Disease; 27 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 49 interventional studies indexed under Lyme Disease.

Browse Lyme Disease studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children consulting for peripheral facial palsy

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Telephonic interview

    Parents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not

    Other: telephonic interview

Interventions

  • Othertelephonic interview

    Telephonic interview

06

What researchers measure

Primary outcomes

  1. 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: I. Normal II. Mild dysfunction III. Moderate dysfunction IV. Moderately severe dysfunction

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
  • CHU Besancon
    Besançon, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03981874
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Jun 11, 2019
Start date
May 29, 2019
Primary completion
Jul 29, 2019 (estimated)
Completion
Jul 29, 2019 (estimated)
Last update
Jun 12, 2019

Study contacts

Candice Feuillebois, Int
Contact
sydnak@hotmail.fr
+33381218516
Raphael Anxionnat, MD
Contact
ranxionnat@chu-besancon.fr
+33381218516
Raphael Anxionnat, MD
principal investigator · CHU Besançon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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