Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children

Lyme Disease Clinical Trial

— LYMEPED  

Official title:

Comparative Study of Peripheral Facial Paralysis Sequelae Based on the Initial Medical Care of Lyme Disease Among Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981874
• Other study ID #: P/2019/419
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: July 29, 2019

Study information

• Verified date: June 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Candice Feuillebois, Int
• Phone: +33381218516
• Email: sydnak[@]hotmail.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 29, 2019
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Children consulting for peripheral facial palsy

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

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Lyme Disease
• Paralysis

Intervention

Other:
• telephonic interview
Telephonic interview

Locations

Country	Name	City	State
France	CHU Besancon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 years