Contribution of Inflammation and Neuronal Integrity Markers in Patients With First-episode Conversive Motor Disorder (HYCOIN)

Conversion disorders, also called "dissociative disorders" (ICD-10), or "functional neurological disorders" (DSM-5), are a common condition, with a prevalence of 1-10% in medical and surgical inpatients (Toone 1990), and 10-30% in neurology patients (Carson et al. 2000).

They are characterized by the presence of symptoms or deficits affecting voluntary motor, sensory, or sensory functions suggestive of a neurological or general medical condition in combination with psychological factors. Functional neurological disorder is currently a diagnosis of elimination and its treatment remains uncodified. A better understanding of the pathophysiology of this disorder is needed to improve the diagnostic and therapeutic approach to this condition.

Identifying new biological markers associated with motor symptoms occurring during the course of the functional neurological disorder would allow clinicians to acquire new diagnostic methods, to improve therapeutic means and their specificity and to highlight possible predictive factors of the clinical evolution of this pathology. At the same time, the identification of biological markers associated with motor symptoms will allow the patient to better understand and accept the diagnosis, and thus to better adhere to the proposed treatment.

Study Overview

• Status: Completed
• Conditions: Conversion Disorder
• Intervention / Treatment: Diagnostic test: blood inflammatory markers (TNF-α, IL1ra, RsIL-2, IL-6, IL-10, IL-18, IFNγ, MCP-1/CCL2 GFAP)

Detailed Description

This project is an ancillary study carried out from the cohort of patients included in the HYCORE protocol "PET-Scan evaluation of metabolic abnormalities associated with the clinical evolution at 6 months of patients suffering from a motor conversion disorder" (RCB N°: 2014-A01159-38) of which the CHU of Nîmes is the promoter. In the HYCORE project, 20 patients suffering from a first episode of motor conversion disorder (with paralysis, motor weakness or abnormal movements according to DSM-IV criteria) in acute phase (evolving for less than one month) recruited in the neurology and psychiatry departments of the University Hospital of Montpellier and Nîmes are included.

Thinvestigtor plan to use the biological samples collected in the HYCORE project for the determination of markers of inflammation and neurofilaments (GFAP & NfL); the levels of inflammatory markers thus obtained will be put into perspective in relation to the cerebral metabolism observed by PET-scan as well as the persistence of a motor handicap (EDSS score) evaluated in the HYCORE study.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Choisir Une Région
    • Nîmes, Choisir Une Région, France, 30029
      • Ismael CONEJERO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

20 patients with paralysis, motor weakness or abnormal movements corresponding to the DSM-IV criteria of conversive motor disorder consulting the SAU or the Neurology departments of the CHU of Nîmes and Montpellier already included in the HYCORE mother study.

Description

Inclusion Criteria:

• The patient must have given free and informed consent and signed the consent.
• Patient must be enrolled in or a beneficiary of a health insurance plan.
• Patient's age is > 18 and ≤ 65 years.
• Patient meets DSM-IV criteria for conversive motor disorder (with paralysis, motor weakness, or abnormal movements) evolving for less than 1 month and is euthymic (HAMD score < or =7 assessed by a psychiatrist).
• First episode (incident case)
• The last symptom is less than one month old.
• The patient is not on neuroleptics.

Exclusion Criteria:

• Subject is participating in another study
• Subject is in an exclusion period determined by a previous study
• Subject is under court protection, guardianship, or conservatorship
• The subject refuses to sign the consent form
• It is impossible to provide the subject with informed information
• The patient is pregnant, parturient, or nursing
• Specialized neurological clinical examination and brain and spinal cord MRI reveal organic neurological damage
• The subject presents a HAMD score >7
• Subject has a current manic or hypomanic episode, a current diagnosis of substance abuse/dependence (excluding tobacco), a lifetime diagnosis of schizophrenia, or a chronic neurological condition (active epilepsy, stroke, brain tumor)
• Suicidal or high-risk subjects (assessed using the MINI)
• The subject has a contraindication to the performance of a PET scan
• Patient is on neuroleptic medication at inclusion
• The last symptom is more than one month old
• The patient has already had an episode (prevalent case).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with conversive motor disorder; Patients with paralysis, motor weakness or abnormal movements meeting the DSM-IV criteria of conversive motor disorder consulting the SAU or the Neurology departments of the CHU of Nîmes and Montpellier included in the HYCORE parent study (RCB ID 2014-A01159-38, NCT02329626)	Diagnostic test: blood inflammatory markers (TNF-α, IL1ra, RsIL-2, IL-6, IL-10, IL-18, IFNγ, MCP-1/CCL2 GFAP); Bioassays of blood inflammatory markers (TNF-α, IL1ra, RsIL-2, IL-6, IL-10, IL-18, IFNγ, MCP-1/CCL2 GFAP) from sera babcocked in the HYCORE mother study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNF-α	Correlation between blood TNF-α and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline
IL1ra	Correlation between blood IL1ra and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline
RsIL-2	Correlation between blood RsIL-2 and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline
IL-6	Correlation between blood IL-6 and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline
IL-10	Correlation between blood IL-10 and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline
IL-18	Correlation between blood IL-18 and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline
IFNγ	Correlation between blood IFNγ and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline
MCP-1/CCL2	Correlation between blood MCP-1/CCL2 and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline
GFAP	Correlation between blood GFAP and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• Conejero I, Thouvenot E, Hingray C, Hubsch C, El-Hage W, Carle-Toulemonde G, Rotge JY, Drapier S, Drapier D, Mouchabac S. [Understanding functional neurological disorders: From biological markers to pathophysiological models]. Encephale. 2023 Aug;49(4S):S18-S23. doi: 10.1016/j.encep.2023.06.003. Epub 2023 Jul 1. French.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Somatoform Disorders; Conversion Disorder; Antirheumatic Agents; Interleukin 1 Receptor Antagonist Protein
• Other Study ID Numbers: Local/2021/IC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No