ClinicalTrials.gg
CompletedNCT05305014HYCOINUpdated Nov 17, 2025

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

An observational study in Conversion Disorder, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Conversion Disorder

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03

In context

Conversion Disorder

89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 37 observational studies indexed under Conversion Disorder.

Browse Conversion Disorder studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patient must have given free and 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 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

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 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).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testblood 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: Baseline

  7. 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.

    Time frame: Baseline

  8. 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.

    Time frame: Baseline

  9. 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.

    Time frame: Baseline

07

Study locations

1 site
  • Ismael CONEJERO
    Nîmes, Choisir Une Région 30029, France
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References and documents

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. PubMed 37394415 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Apr 2022, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2022
First posted
Mar 31, 2022
StartActual
Apr 1, 2022
Primary completionActual
Apr 15, 2022
CompletionActual
Apr 15, 2022
Last update
Nov 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05305014
Responsible party
Sponsor
First posted
Mar 31, 2022
Start date
Apr 1, 2022
Primary completion
Apr 15, 2022
Completion
Apr 15, 2022
Last update
Nov 17, 2025

Study contacts

Anissa MEGZARI
study director · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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