Subjective Perception of Motor Control During Psychogenic... | NCT02843932

Studies
Subjective Perception of Motor Control During Psychogenic Disorders

NCT02843932

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Nov 18, 2020Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Somatoform Disorders

Interventions

functional brain MRI

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment difficulties

Expanded Access Info

Start Date

May 13, 2015Actual

Primary Completion Date

Jun 2019Actual

Completion Date

Jun 2019Actual

First Submitted Date

May 12, 2015

First Submission Date that Met QC Criteria

Jul 22, 2016

First Posted Date

Jul 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2020

Last Update Posted Date

Nov 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to reveal neurobiological bases of the motor control of conscious perception, thanks to new techniques of functional cerebral imaging (MRI), and potentials deteriorations connected to neuropsychiatric disorders like conversion disorder.

The Hospital University Center of Grenoble will provide patients from Neurology department, characterized with non psychogenic epileptic seizures and abnormal psychogenic movements, from conversive origin.

Subjects will be scanned by Magnetic Resonance Imaging during a motor paradigm inducing a perceptive conflict between two informations : proprioceptive information coming from the action (drawing) and visual information (draw's mark) that appears on the screen when there is movement.

Detailed Description

New results will be provided about brain mechanisms involved in motor control perception among healthy patients and patients suffering from functional neurologic symptoms.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psychogenic disorders	Experimental	Psychogenic movement disorders and seizures	Other: functional brain MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
functional brain MRI	Other	functional imagery during motor-perception tasks	Psychogenic disorders

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Familiarization with the joystick.	HHSC-JOY-I from Current Designs. They are asked to trace a straight line.	30 minutes
Brain MRI		One hour and a half

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Medical exam médical done before study participation
Between 18 and 65 years
Right-handed persons
Conversion disorder based on DSM IV-R criterias
Symptom affecting motor system, like abnormal movements (shivers, dystonia, parkinsonism, or problem when walking)

Exclusion Criteria:

Subjects included in a clinical and/or therapeutic exeprimentation in progress
People with MRI contraindications : prosthesis or metal implants, metallic teeth (dental) brace, pacemaker, IUD, possibility of pregnancy, claustrophobia
Traitement médicamenteux psychotrope ou susceptible d'interférer avec le débit sanguin cérébral ou l'activité neuronale
History of brain or disseminated and extendible lesions of white matter, of an other degenerative morbidity, a confusion or an insanity as well as serious deficits preventing language understanding.
Alcohol ingestion
Pregnant, parturient or breastfeeding women
All other categories of protected persons

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Tiphaine Montagnon	DRCI, CHU GRENOBLE, FRANCE	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Chu Grenoble		Grenoble		38043	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11058820	Background	Desmurget M, Grafton S. Forward modeling allows feedback control for fast reaching movements. Trends Cogn Sci. 2000 Nov 1;4(11):423-431. doi: 10.1016/s1364-6613(00)01537-0.
7569931	Background	Wolpert DM, Ghahramani Z, Jordan MI. An internal model for sensorimotor integration. Science. 1995 Sep 29;269(5232):1880-2. doi: 10.1126/science.7569931.