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

NCT05305014 | Completed

• 1 other identifier: Local/2021/IC-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Conversion Disorder

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

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)

Interventions

blood inflammatory markers (TNF-α, IL1ra, RsIL-2, IL-6, IL-10, IL-18, IFNγ, MCP-1/CCL2 GFAP) DIAGNOSTIC_TEST

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.

Patient with conversive motor disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subject is participating in another 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
• The last symptom is more than one month old
• The patient has already had an episode (prevalent case).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Ismael CONEJERO

Nîmes, Choisir Une Région, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 37394415 RESULT

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Anissa MEGZARI

  Centre Hospitalier Universitaire de Nīmes

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: April 1, 2022
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: November 17, 2025

Record last verified: 2023-05

Locations

FR (1)