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

Conversion Disorder Clinical Trial

— HYCORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329626
• Other study ID #: LOCAL/2014/ETIC-01
• Secondary ID: 2014-A01159-38
• Status: Completed
• First received: December 29, 2014
• Last updated: March 23, 2018
• Start date: January 29, 2016
• Est. completion date: January 15, 2018

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Conversion Disorder
• Disease
• Dissociative Disorders

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHRU de Montpellier - Hôpital Gui de Chauliac	Montpellier Cedex 5
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of a modified Ranking score > 1		6 months
Primary	Presence/absence of a metabolic anomoly according to PET CT 18 FDG	PET CT 18 FDG = Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography	Day 0 to Day 15
Secondary	Presence/absence of a metabolic anomoly according to PET CT 18 FDG		3 months
Secondary	Modified Rankin Score		3 months
Secondary	Modified Rankin Score		6 months
Secondary	EDSS score		Day 0 to Day 15
Secondary	EDSS score		3 months
Secondary	EDSS score		6 months
Secondary	NIHSS score		Day 0 to Day 15
Secondary	NIHSS score		3 months
Secondary	NIHSS score		6 months
Secondary	MINI questionnaire		Day 0 to Day 15
Secondary	HAMD scale		Day 0 to Day 15
Secondary	HAMD scale		3 months
Secondary	HAMD scale		6 months
Secondary	HADS scale		Day 0 to Day 15
Secondary	HADS scale		3 months
Secondary	HADS scale		6 months
Secondary	WHO score		3 months
Secondary	WHO score		6 months