Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children

NCT03981874 | Unknown

• 1 other identifier: P/2019/419
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lyme Disease

Keywords

neuroborreliosis; facial palsy; children

Outcome Measures

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

  4 years

Study Arms (1)

Telephonic interview

EXPERIMENTAL

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

Other: telephonic interview

Interventions

telephonic interview OTHER

Telephonic interview

Telephonic interview

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children consulting for peripheral facial palsy

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besancon

Besançon, France

RECRUITING

MeSH Terms

Conditions

Lyme Disease; Facial Paralysis

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raphael Anxionnat, MD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candice Feuillebois, Int

CONTACT

+33381218516; sydnak@hotmail.fr

Raphael Anxionnat, MD

CONTACT

+33381218516; ranxionnat@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: May 29, 2019
• Primary Completion: July 29, 2019
• Study Completion: July 29, 2019
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)