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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Conversion Disorder

Treatments

Device: PET CT 18 FDG

Study type

Observational

Funder types

Other

Identifiers

NCT02329626
LOCAL/2014/ETIC-01
2014-A01159-38 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

20 participants in 1 patient group

Study population
Description:
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
Treatment:
Device: PET CT 18 FDG

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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