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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329626
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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).

Condition or disease Intervention/treatment
Conversion Disorder 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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation Via PET Scan of Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder
Actual Study Start Date : January 29, 2016
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Blood samples will be taken at baseline, 3 months and 6 months.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329626


Locations
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France
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier Cedex 5, France, 34295
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Ismaël Conejero Centre Hospitalier Universitaire de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02329626    
Other Study ID Numbers: LOCAL/2014/ETIC-01
2014-A01159-38 ( Other Identifier: RCB number )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Conversion Disorder
Hysteria
Dissociative Disorders
Somatoform Disorders
Mental Disorders
Histrionic Personality Disorder
Personality Disorders
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action