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

NCT05742139 | Completed

• 1 other identifier: 2022-A01583-40
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuroborreliosis, Lyme; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Imputability according to the patient of his pain in relation to the initial infection

  At inclusion

• Comparison of symptoms and/or quality of life between patients with definite versus probable neuroborreliosis using the SF-36 questionnaire

  At inclusion

Study Arms (2)

Patient group

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

Other: Non intervention

Control group

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;

Other: Non intervention

Interventions

Non intervention OTHER

Non intervention

Control group; Patient group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A online questionnaire is completed by the patient concerning socio-demographic date, patient history, quality of life scale, persistent neurological symptoms

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hopital Nord Franche-Comte: lead

Study Sites (2)

CHU Besançon

Besançon, 25000, France

Location

Hôpital Nord Franche-Comté

Trévenans, 90400, France

Location

MeSH Terms

Conditions

Lyme Neuroborreliosis

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Lyme Disease; Gram-Negative Bacterial Infections; Borrelia Infections; Spirochaetales Infections; Central Nervous System Infections; Tick-Borne Diseases; Vector Borne Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: February 23, 2023
• Study Start: February 27, 2023
• Primary Completion: August 24, 2023
• Study Completion: October 27, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)