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Clinical Trials/NCT02329626
NCT02329626
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes3 sites in 1 country20 target enrollmentJanuary 29, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Conversion Disorder
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
20
Locations
3
Primary Endpoint
Presence/absence of a modified Ranking score > 1
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 29, 2016
End Date
January 15, 2018
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Presence/absence of a modified Ranking score > 1

Time Frame: 6 months

Presence/absence of a metabolic anomoly according to PET CT 18 FDG

Time Frame: Day 0 to Day 15

PET CT 18 FDG = Positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose integrated with computed tomography

Secondary Outcomes

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

Study Sites (3)

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