Impact on the Quality of Life and Persistent Symptoms of Patients Away From Diagnosed and Treated Neuroborreliosis

Completed

• Conditions: Quality of Life; Neuroborreliosis, Lyme
• Interventions: Other: Non intervention

• Registration Number: NCT05742139
• Lead Sponsor: Hopital Nord Franche-Comte

Brief Summary

The link between Lyme neuroborreliosis (NBL) and persistent symptoms is debated in the medical world. Some report a frequency of post NBL symptoms similar to the general population, and others define a specific entity, the PTLDS (Post Treatment Lyme Disease Symptoms).

In France, few studies have evaluated the persistent symptoms and the impact on the quality of life of patients after treatment for NBL.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-02-27
• Primary Completion: 2023-08-24
• Status Verified: 2023-10
• Study Completion: 2023-10-27
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Have been hospitalized or consulted for neuroborreliosis between 2010 and 2021;
• Have a diagnosis of probable neuroborreliosis (compatible clinical signs + lumbar puncture with positive intrathecal synthesis of immunoglobulins) or certain (compatible clinical signs + lumbar puncture with pleocytosis and positive intrathecal synthesis of immunoglobulins);
• Have received adequate treatment according to the recommendations (1st intention DOXYCYCLINE 100mgx2/day or 2nd intention CEFTRIAXONE IV 2g/day for 14 to 21

Exclusion Criteria

• Be part of the entourage of the cases;
• Do not have ATCD of Lyme borreliosis (especially erythema migrans);
• Not having been bitten by a tick in the last 5 years;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient group	Non intervention	Have been hospitalized or consulted for neuroborreliosis between 2010 and 2021; Have a diagnosis of probable neuroborreliosis (compatible clinical signs + lumbar puncture with positive intrathecal synthesis of immunoglobulins) or certain (compatible clinical signs + lumbar puncture with pleocytosis and positive intrathecal synthesis of immunoglobulins); Have received adequate treatment according to the recommendations (1st intention DOXYCYCLINE 100mgx2/day or 2nd intention CEFTRIAXONE IV 2g/day for 14 to 21
Control group	Non intervention	Be part of the entourage of the cases; Do not have ATCD of Lyme borreliosis (especially erythema migrans); Not having been bitten by a tick in the last 5 years;

Primary Outcome Measures

Name	Time	Method
Assess the quality of life of patients compared to a healthy control population using the SF-36 questionnaire and the Fatigue Scale Severity	At inclusion
Identification of symptoms recognized by the patient as persistent after neuroboreliosis from a list of referenced symptoms	At inclusion

Secondary Outcome Measures

Name	Time	Method
Comparison of symptoms and/or quality of life between patients with definite versus probable neuroborreliosis using the SF-36 questionnaire	At inclusion
Imputability according to the patient of his pain in relation to the initial infection	At inclusion

Trial Locations

Locations (2)

CHU Besançon; 🇫🇷 Besançon, France

Hôpital Nord Franche-Comté; 🇫🇷 Trévenans, France