Clinical trial NCT02329626: Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder
Official title: Evaluation Via PET Scan of Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conversion Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients with paralysis, motor weakness or abnormal movements meeting DSM-IV criteria for motor conversion disorder consulting via the Emergency or Neurology department of participating centers.

Brief summary: The main objective of this study is to make a first evaluation of the relationship between metabolic abnormalities objectified by Positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose integrated with computed tomography (PET CT 18 FDH) performed at rest at the onset of symptoms in patients with a first episode of motor conversion disorder and the persistence of a motor disability at 6 months measured by the modified Rankin score (mRS).

Detailed description: The secondary objectives of this study are:

A. To assess whether metabolic abnormalities objectified by PET CT 18 FDH performed at rest at the onset of symptoms may be predictive of persistent disability at 6 months as measured by the EDSS, the NIHSS and WHO status.

B. To assess whether metabolic abnormalities objectified by PET CT 18 FDH performed at rest at 3 months after diagnosis may be predictive of persistent motor disability at 6 months (EDSS, NIHSS, mRS, WHO) C. To search for and characterize any abnormalities of metabolism objectified in the initial PET CT 18 FDH predictive of persistent motor disability at 3 months.

D. To determine if there are persistent metabolic abnormalities 3 months post-diagnosis independently of the clinical course (marker trait).

E. Define the brain areas whose metabolism is often altered in patients with motor conversion disorders.

F. Establish a collection of biological samples from patients for future research studies of prognostic biomarkers of a motor conversion disorder.

Eligibility criteria: Inclusion Criteria:

* The patient must have given free and informed consent and signed the consent
* The patient must be affiliated with or beneficiary of a health insurance plan
* The patient meets DSM-IV criteria for motor conversion disorder (with paralysis, motor weakness or abnormal movements) lasting for less than 1 month and euthymic (HAMD score \< or = 7, as evaluated by a psychiatrist)
* First episode (incident cases)
* The latest symptom dates to within a month
* The patient is not under neuroleptics

Exclusion Criteria:

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The subject is under judicial protection, guardianship or curatorship
* The subject refuses to sign the consent
* It is not possible to correctly inform the patient
* The patient is pregnant, parturient or she is breastfeeding
* Specialized clinical neurological examination and brain and spinal cord MRI revealed an organic neurological cause
* The subject has a HAMD score \> 7
* The subject currently has manic/hypomanic episode, a diagnosis of substance abuse or dependency (excluding tobacco), a diagnosis of schizophrenia (any time in the past) or chronic neurological disease (active epilepsy, stroke, brain tumor)
* Suicidal or high risk for suicide (according to MINI assessment)
* Contra-indication for a PET scan
* Patient under neuroleptics at inclusion
* The last symptom happened over 1 month ago
* The patient has had previous episodes (prevalent cases)

Primary outcomes:
measure: Presence/absence of a modified Ranking score > 1
timeFrame: 6 months
measure: Presence/absence of a metabolic anomoly according to PET CT 18 FDG
timeFrame: Day 0 to Day 15
Secondary outcomes:
measure: Presence/absence of a metabolic anomoly according to PET CT 18 FDG
timeFrame: 3 months
measure: Modified Rankin Score
timeFrame: 3 months
measure: Modified Rankin Score
timeFrame: 6 months
measure: EDSS score
timeFrame: Day 0 to Day 15
measure: EDSS score
timeFrame: 3 months
measure: EDSS score
timeFrame: 6 months
measure: NIHSS score
timeFrame: Day 0 to Day 15
measure: NIHSS score
timeFrame: 3 months
measure: NIHSS score
timeFrame: 6 months
measure: MINI questionnaire
timeFrame: Day 0 to Day 15
measure: HAMD scale
timeFrame: Day 0 to Day 15
measure: HAMD scale
timeFrame: 3 months
measure: HAMD scale
timeFrame: 6 months
measure: HADS scale
timeFrame: Day 0 to Day 15
measure: HADS scale
timeFrame: 3 months
measure: HADS scale
timeFrame: 6 months
measure: WHO score
timeFrame: 3 months
measure: WHO score
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: CHRU de Montpellier - Hôpital Gui de Chauliac
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Ismaël Conejero
role: STUDY_DIRECTOR
References: