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Completed

NCT Number: NCT02329626

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Montpellier - Hôpital Gui de Chauliac, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PET CT 18 FDG

Device

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.

Primary outcomes

  1. Presence/absence of a modified Ranking score > 1

    Time frame: 6 months

  2. 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

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

    Time frame: 3 months

  2. Modified Rankin Score

    Time frame: 3 months

  3. Modified Rankin Score

    Time frame: 6 months

  4. EDSS score

    Time frame: Day 0 to Day 15

  5. EDSS score

    Time frame: 3 months

  6. EDSS score

    Time frame: 6 months

  7. NIHSS score

    Time frame: Day 0 to Day 15

  8. NIHSS score

    Time frame: 3 months

  9. NIHSS score

    Time frame: 6 months

  10. MINI questionnaire

    Time frame: Day 0 to Day 15

  11. HAMD scale

    Time frame: Day 0 to Day 15

  12. HAMD scale

    Time frame: 3 months

  13. HAMD scale

    Time frame: 6 months

  14. HADS scale

    Time frame: Day 0 to Day 15

  15. HADS scale

    Time frame: 3 months

  16. HADS scale

    Time frame: 6 months

  17. WHO score

    Time frame: 3 months

  18. WHO score

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: HYCORE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 31, 2014
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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