NCT07341997

Brief Summary

Peripheral neuropathies (PN) affect 1% of the global population, particularly the elderly. About 20-30% of cases remain unexplained. In French Guiana, we hypothesize that factors like neurotoxic traditional plant remedies, arboviral disease outbreaks, and mercury exposure from illegal gold mining may contribute to PN. The study aims to assess the association between PN and exposure to arboviral infections, heavy metals, and plant consumption in French Guiana.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Dec 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Dec 2025Jul 2027

Study Start

First participant enrolled

December 8, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 15, 2026

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

January 6, 2026

Last Update Submit

January 6, 2026

Conditions

Keywords

Preipheral neuropathiesFrench guianaMercuryLeadArbovirusesEnvironment

Outcome Measures

Primary Outcomes (1)

  • Comparison of exposure rates among cases and controls

    The primary endpoint will be the comparison of rates of exposure to arboviruses, heavy metals and consumption of potentially neurotoxic plants in cases and controls. The heavy metals assay and the questionnaire will be carried out at the inclusion visit.

    At inclusion

Secondary Outcomes (2)

  • Genetic mutations indentification

    At inclusion

  • Peripheral Nerve Disability (PND) determination

    At inclusion

Study Arms (1)

Control group

ACTIVE COMPARATOR

Patients hospitalised or consulting at hospitals in Cayenne and Saint-Laurent du Maroni who do not have peripheral neuropathy.

Other: Case Group

Interventions

Patients diagnosed with diabetic peripheral neuropathy or chronic idiopathic axonal polyneuropathy.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For the Case group: patients diagnosed with diabetic peripheral neuropathy or chronic idiopathic axonal polyneuropathy
  • For the Control group: patients hospitalized or consulting at the hospitals in Cayenne and Saint-Laurent du Maroni, without peripheral neuropathy.

You may not qualify if:

  • For the Case and Control groups: patients under the age of 18, those who object to participation and those who are unable to complete the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier de Cayenne

Cayenne, 97300, French Guiana

RECRUITING

Centre Hospitalier de l'Ouest Guyanais

Saint-Laurent-du-Maroni, 97320, French Guiana

RECRUITING

Related Publications (12)

  • Nacher M, Ouedraogo E, Succo T, Guarmit B, Djossou F, Stettler L, Alvarez F, Elenga N, Adenis A, Couppié P. L'infection VIH en Guyane: revue historique et tendances actuelles. Bull Epidemiol Hebd. 2020;2-3:43-51. http://beh. santepubliquefrance.fr/beh/2020/2-3/pdf/2020_2-3_2.pdf.

    BACKGROUND
  • Cardoso * T. BA. Le mercure en Guyane française : synthèse des études d'imprégnation et d'impact sanitaires menées de 1994 à 2005. Bulletin Epidémiologique Hebdomadaire - BEH. 2010 Apr;13:118-20.

    BACKGROUND
  • Lernould B. Intoxications à la Bita dans le bassin du Maroni en 2011, série de 4 cas, aspects cliniques et paracliniques, botaniques et de santé publique. Th Doc Méd. Université du Droit et de la Santé - Lille 2, Lille, France. 2013. https://pepite- depot.univ-lille.fr/LIBRE/Th_Medecine/2013/2013LIL2M304. pdf.

    BACKGROUND
  • Graille J, Blaizot R, Darrigade AS, Sainte-Marie D, Nacher M, Schaub R, Couppie P. Leprosy in French Guiana 2007-2014: a re-emerging public health problem. Br J Dermatol. 2020 Jan;182(1):237-239. doi: 10.1111/bjd.18334. Epub 2019 Sep 8. No abstract available.

    PMID: 31286485BACKGROUND
  • Sabbah N, Carles G, Demar M, Nacher M. Diabetes in French Guiana, adapting national standards of therapeutic education and care to the amazonian challenge. World J Diabetes. 2021 Feb 15;12(2):98-107. doi: 10.4239/wjd.v12.i2.98.

    PMID: 33594330BACKGROUND
  • Maurice L, Barraza F, Blondet I, Ho-A-Chuck M, Tablon J, Brousse P, Demar M, Schreck E. Childhood lead exposure of Amerindian communities in French Guiana: an isotopic approach to tracing sources. Environ Geochem Health. 2021 Nov;43(11):4741-4757. doi: 10.1007/s10653-021-00944-9. Epub 2021 May 11.

    PMID: 33974199BACKGROUND
  • Matos LM, Borges AT, Palmeira AB, Lima VM, Maciel EP, Fernandez RNM, Mendes JPL, Romero GAS. Frequency of exposure to arboviruses and characterization of Guillain Barre syndrome in a clinical cohort of patients treated at a tertiary referral center in Brasilia, Federal District. Rev Soc Bras Med Trop. 2022 Apr 8;55:e03062021. doi: 10.1590/0037-8682-0306-2021. eCollection 2022.

    PMID: 35416870BACKGROUND
  • Maury-Brachet R, Gentes S, Dassie EP, Feurtet-Mazel A, Vigouroux R, Laperche V, Gonzalez P, Hanquiez V, Mesmer-Dudons N, Durrieu G, Legeay A. Mercury contamination levels in the bioindicator piscivorous fish Hoplias aimara in French Guiana rivers: mapping for risk assessment. Environ Sci Pollut Res Int. 2020 Feb;27(4):3624-3636. doi: 10.1007/s11356-018-3983-x. Epub 2019 Jan 4.

    PMID: 30610584BACKGROUND
  • Laperche V, Hellal J, Maury-Brachet R, Joseph B, Laporte P, Breeze D, Blanchard F. Regional distribution of mercury in sediments of the main rivers of French Guiana (Amazonian basin). Springerplus. 2014 Jun 26;3:322. doi: 10.1186/2193-1801-3-322. eCollection 2014.

    PMID: 25045610BACKGROUND
  • Schmidt HH, Waddington-Cruz M, Botteman MF, Carter JA, Chopra AS, Hopps M, Stewart M, Fallet S, Amass L. Estimating the global prevalence of transthyretin familial amyloid polyneuropathy. Muscle Nerve. 2018 May;57(5):829-837. doi: 10.1002/mus.26034. Epub 2018 Feb 1.

    PMID: 29211930BACKGROUND
  • Pasnoor M, Nascimento OJ, Trivedi J, Wolfe GI, Nations S, Herbelin L, de Freitas MG, Quintanilha G, Khan S, Dimachkie M, Barohn R. North America and South America (NA-SA) neuropathy project. Int J Neurosci. 2013 Aug;123(8):563-7. doi: 10.3109/00207454.2013.782026. Epub 2013 Apr 17.

    PMID: 23461611BACKGROUND
  • Hanewinckel R, van Oijen M, Ikram MA, van Doorn PA. The epidemiology and risk factors of chronic polyneuropathy. Eur J Epidemiol. 2016 Jan;31(1):5-20. doi: 10.1007/s10654-015-0094-6. Epub 2015 Dec 23.

    PMID: 26700499BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Diagnosis-Related Groups

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Prospective Payment SystemReimbursement MechanismsInsurance, Health, ReimbursementFinancing, OrganizedEconomicsHealth Care Economics and Organizations

Study Officials

  • Mathieu NACHER

    Centre Hospitalier de Cayenne

    STUDY CHAIR

Central Study Contacts

Nathalie DESCHAMPS, Principal Investigator

CONTACT

Vincent De Paul SENEKIAN, Principal Investigator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a prospective multicenter case-control study being conducted in hospitals in Cayenne and Saint-Laurent du Maroni. At the inclusion visit, blood samples will be taken to assess arbovirus serology, particularly for Zika, Chikungunya and Dengue, as well as to measure levels of heavy metals, including mercury and lead. In addition, urine and hair samples will be taken to analyze these heavy metals. Participants will also fill in a questionnaire about their plant consumption.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nathalie DESCHAMPS

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 15, 2026

Study Start

December 8, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 15, 2026

Record last verified: 2025-07

Locations