Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children (LYMEPED)

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.

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 Overview

• Status: Unknown
• Conditions: Lyme Disease
• Intervention / Treatment: Other: telephonic interview

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Candice Feuillebois, Int; Phone Number: +33381218516; Email: sydnak@hotmail.fr
• Study Contact Backup: Name: Raphael Anxionnat, MD; Phone Number: +33381218516; Email: ranxionnat@chu-besancon.fr

Study Locations

• France
  • Besançon, France
    • Recruiting
    • CHU Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Telephonic interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Raphael Anxionnat, MD, CHU Besançon

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Anticipated): July 29, 2019
• Study Completion (Anticipated): July 29, 2019

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: children; neuroborreliosis; facial palsy
• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; Vector Borne Diseases; DNA Virus Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Cranial Nerve Diseases; Herpesviridae Infections; Tick-Borne Diseases; Facial Nerve Diseases; Borrelia Infections; Spirochaetales Infections; Paralysis; Lyme Disease; Bell Palsy; Facial Paralysis
• Other Study ID Numbers: P/2019/419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No