Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder (HYCORE)

Evaluation Via PET Scan of Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder

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).

Study Overview

• Status: Completed
• Conditions: Conversion Disorder
• Intervention / Treatment: Device: PET CT 18 FDG

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU de Montpellier - Hôpital Lapeyronie
  • Montpellier Cedex 5, France, 34295
    • CHRU de Montpellier - Hôpital Gui de Chauliac
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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. Intervention: PET CT 18 FDG	Device: PET CT 18 FDG; Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography. This intervention is required for the observational needs of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence/absence of a modified Ranking score > 1		6 months
Presence/absence of a metabolic anomoly according to PET CT 18 FDG	PET CT 18 FDG = Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography	Day 0 to Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Presence/absence of a metabolic anomoly according to PET CT 18 FDG	3 months
Modified Rankin Score	3 months
Modified Rankin Score	6 months
EDSS score	Day 0 to Day 15
EDSS score	3 months
EDSS score	6 months
NIHSS score	Day 0 to Day 15
NIHSS score	3 months
NIHSS score	6 months
MINI questionnaire	Day 0 to Day 15
HAMD scale	Day 0 to Day 15
HAMD scale	3 months
HAMD scale	6 months
HADS scale	Day 0 to Day 15
HADS scale	3 months
HADS scale	6 months
WHO score	3 months
WHO score	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Ismaël Conejero, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2016
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: December 29, 2014
• First Submitted That Met QC Criteria: December 30, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 23, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Somatoform Disorders; Histrionic Personality Disorder; Dissociative Disorders; Conversion Disorder; Hysteria; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: LOCAL/2014/ETIC-01; 2014-A01159-38 (Other Identifier: RCB number)