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

Impact Sur la qualité de Vie et symptômes Persistants Des Patients à Distance d'Une neuroborréliose diagnostiquée et traitée

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05742139

Acronym

QoLyme

Enrollment

159

Registered

2023-02-23

Start date

2023-02-27

Completion date

2023-10-27

Last updated

2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroborreliosis, Lyme, Quality of Life

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.

Interventions

OTHERNon intervention

Non intervention

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026