Clinical Trial: Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Evaluation Via PET Scan of Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder
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 Summary:
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.
Sponsor: Centre Hospitalier Universitaire de Nīmes
Current Primary Outcome:
- 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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Presence/absence of a metabolic anomoly according to PET CT 18 FDG [ Time Frame: 3 months ]
- Modified Rankin Score [ Time Frame: 3 months ]
- Modified Rankin Score [ Time Frame: 6 months ]
- EDSS score [ Time Frame: Day 0 to Day 15 ]
- EDSS score [ Time Frame: 3 months ]
- EDSS score [ Time Frame: 6 months ]
- NIHSS score [ Time Frame: Day 0 to Day 15 ]
- NIHSS score [ Time Frame: 3 months ]
- NIHSS score [ Time Frame: 6 months ]
- MINI questionnaire [ Time Frame: Day 0 to Day 15 ]
- HAMD scale [ Time Frame: Day 0 to Day 15 ]
- HAMD scale [ Time Frame: 3 months ]
- HAMD scale [ Time Frame: 6 months ]
- HADS scale [ Time Frame: Day 0 to Day 15 ]
- HADS scale [ Time Frame: 3 months ]
- HADS scale [ Time Frame: 6 months ]
- WHO score [ Time Frame: 3 months ]
- WHO score [ Time Frame: 6 months ]
Original Secondary Outcome:
- Presence/absence of a metabolic anomoly according to PET CT 18 FDG [ Time Frame: 3 months ]
- Modified Rankin Score [ Time Frame: 3 months ]
- Modified Rankin Score [ Time Frame: 6 months ]
- EDSS score [ Time Frame: Day 0 ]
- EDSS score [ Time Frame: 3 months ]
- EDSS score [ Time Frame: 6 months ]
- NIHSS score [ Time Frame: Day 0 ]
- NIHSS score [ Time Frame: 3 months ]
- NIHSS score [ Time Frame: 6 months ]
- MINI questionnaire [ Time Frame: Day 0 ]
- HAMD scale [ Time Frame: Day 0 ]
- HAMD scale [ Time Frame: 3 months ]
- HAMD scale [ Time Frame: 6 months ]
- HADS scale [ Time Frame: Day 0 ]
- HADS scale [ Time Frame: 3 months ]
- HADS scale [ Time Frame: 6 months ]
- WHO score [ Time Frame: Day 0 ]
- WHO score [ Time Frame: 3 months ]
- WHO score [ Time Frame: 6 months ]
Information By: Centre Hospitalier Universitaire de Nīmes
Dates:
Date Received: December 29, 2014
Date Started: January 2016
Date Completion: July 2018
Last Updated: May 23, 2016
Last Verified: February 2016