Conversion DisorderHYCOINNCT05305014
Contribution of Inflammation and Neuronal Integrity Markers in Patients With First-episode Conversive Motor Disorder
An observational study of Conversion Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Conversion Disorder
- What is being tested?
- blood inflammatory markers (TNF-α, IL1ra, RsIL-2, IL-6, IL-10, IL-18, IFNγ, MCP-1/CCL2 GFAP)
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 15 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Conversion Disorder
- Being tested
- blood inflammatory markers (TNF-α, IL1ra, RsIL-2, IL-6, IL-10, IL-18, IFNγ, MCP-1/CCL2 GFAP)
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: blood inflammatory markers (TNF-α, IL1ra, RsIL-2, IL-6, IL-10, IL-18, IFNγ, MCP-1/CCL2 GFAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Apr 2022
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conversion DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305014
- Sponsor's protocol ID
- Local/2021/IC-01
- Acronym
- HYCOIN
- Status last verified
- May 2023
- First submitted
- 21 Mar 2022
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Inflammation and Neuronal Integrity Markers in Patients With First-episode Conversive Motor Disorder
- ClinicalTrials.gov ID
- NCT05305014
- Acronym / sponsor ID
- HYCOIN / Local/2021/IC-01
- Conditions
- Conversion Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with conversive motor disorder | – | Diagnostic Test: blood inflammatory markers (TNF-α, IL1ra, RsIL-2, IL-6, IL-10, IL-18, IFNγ, MCP-1/CCL2 GFAP)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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Patient with conversive motor disorder |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 37394415Conejero 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conversion Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNF-α (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05305014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.