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

Conversion Disorder Clinical Trial

— HYCOIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305014
• Other study ID #: Local/2021/IC-01
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: April 15, 2022

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Conversion Disorder
• Dissociative Disorders
• Inflammation
• Motor Disorders

Intervention

Diagnostic Test:
• blood inflammatory markers (TNF-a, IL1ra, RsIL-2, IL-6, IL-10, IL-18, IFN?, MCP-1/CCL2 GFAP)
Bioassays of blood inflammatory markers (TNF-a, IL1ra, RsIL-2, IL-6, IL-10, IL-18, IFN?, MCP-1/CCL2 GFAP) from sera babcocked in the HYCORE mother study.

Locations

Country	Name	City	State
France	Ismael CONEJERO	Nîmes	Choisir Une Région

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNF-a	Correlation between blood TNF-a and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	IFN?	Correlation between blood IFN? and resting metabolic abnormalities on 18-FDG PET scan in the acute phase of a first episode of conversive motor disorder.	Baseline
Primary	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
Primary	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