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Conversion DisorderHYCORENCT02329626

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

An observational study of Conversion Disorder, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Conversion Disorder
What is being tested?
PET CT 18 FDG
How many people
20 participants
Where
3 sitesFrance
Study dates
29 Jan 2016to 15 Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • CHRU de Montpellier - Hôpital Gui de Chauliac

    Montpellier, 34295

  • CHRU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Official title: Evaluation Via PET Scan of 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).

Read the detailed description

The secondary objectives of this study are:

  1. 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.
  2. 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.
  3. To determine if there are persistent metabolic abnormalities 3 months post-diagnosis independently of the clinical course (marker trait).
  4. Define the brain areas whose metabolism is often altered in patients with motor conversion disorders.
  5. Establish a collection of biological samples from patients for future research studies of prognostic biomarkers of a motor conversion disorder.
Being tested
PET CT 18 FDG
Medical subject headings
Conversion Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET CT 18 FDGDevice

    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 groups in NCT02329626
Study groupRoleWhat they receive
Study populationThe 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
Receives: Device: PET CT 18 FDG

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

  2. 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

    Measured: Day 0 to Day 15

Secondary outcomes (18)

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

    Measured: 3 months

  2. Modified Rankin Score

    Measured: 3 months

  3. Modified Rankin Score

    Measured: 6 months

  4. EDSS score

    Measured: Day 0 to Day 15

  5. EDSS score

    Measured: 3 months

  6. EDSS score

    Measured: 6 months

  7. NIHSS score

    Measured: Day 0 to Day 15

  8. NIHSS score

    Measured: 3 months

  9. NIHSS score

    Measured: 6 months

  10. MINI questionnaire

    Measured: Day 0 to Day 15

  11. HAMD scale

    Measured: Day 0 to Day 15

  12. HAMD scale

    Measured: 3 months

  13. HAMD scale

    Measured: 6 months

  14. HADS scale

    Measured: Day 0 to Day 15

  15. HADS scale

    Measured: 3 months

  16. HADS scale

    Measured: 6 months

  17. WHO score

    Measured: 3 months

  18. WHO score

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2014 (estimated)
  2. Study start29 Jan 2016
  3. Primary completion15 Jan 2018
  4. Study completion15 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02329626
Sponsor's protocol ID
LOCAL/2014/ETIC-01
Other IDs
2014-A01159-38
Acronym
HYCORE
Status last verified
Mar 2018
First submitted
29 Dec 2014
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29252202

Questions about this trial

What is this clinical trial studying?

An observational study of Conversion Disorder, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence/absence of a modified Ranking score > 1 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02329626, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.

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