NCT02329626

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 29, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

November 21, 2025

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

December 29, 2014

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Presence/absence of a modified Ranking score > 1

    6 months

  • 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 Outcomes (18)

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

    3 months

  • Modified Rankin Score

    3 months

  • Modified Rankin Score

    6 months

  • EDSS score

    Day 0 to Day 15

  • EDSS score

    3 months

  • +13 more secondary outcomes

Study Arms (1)

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

Interventions

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.

Study population

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • The subject is participating in another 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
  • The last symptom happened over 1 month ago
  • The patient has had previous episodes (prevalent cases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHRU de Montpellier - Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • Conejero I, Thouvenot E, Abbar M, Mouchabac S, Courtet P, Olie E. Neuroanatomy of conversion disorder: towards a network approach. Rev Neurosci. 2018 Jun 27;29(4):355-368. doi: 10.1515/revneuro-2017-0041.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken at baseline, 3 months and 6 months.

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Study Officials

  • Ismaël Conejero

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

January 29, 2016

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

November 21, 2025

Record last verified: 2018-03

Locations