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Completed

NCT Number: NCT05305014

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

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.

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Key information

Conditions

Conversion Disorder Mental Disorders Somatoform Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ismael CONEJERO

Nîmes, Choisir Une Région, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. TNF-α

    Time frame: Baseline

    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.

  2. IL1ra

    Time frame: Baseline

    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.

  3. RsIL-2

    Time frame: Baseline

    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.

  4. IL-6

    Time frame: Baseline

    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.

  5. IL-10

    Time frame: Baseline

    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.

  6. IL-18

    Time frame: Baseline

    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.

  7. IFNγ

    Time frame: Baseline

    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.

  8. MCP-1/CCL2

    Time frame: Baseline

    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.

  9. GFAP

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: HYCOIN

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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