IRM Cognition in Patients With Head Trauma | NCT03181373

Studies
IRM Cognition in Patients With Head Trauma

NCT03181373

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Jun 8, 2017Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Brain-damaged Patients

Interventions

Cognitive rehabilitation program

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

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2014Actual

Primary Completion Date

Jul 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

May 9, 2017

First Submission Date that Met QC Criteria

Jun 7, 2017

First Posted Date

Jun 8, 2017Actual

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

Jun 7, 2017

Last Update Posted Date

Jun 8, 2017Actual

Name	Class
Clementel	UNKNOWN
Maurice Gantchoula	UNKNOWN
LADAPT	OTHER
APF

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years period.

Detailed Description

The following data are collected in 3 months, 12 months then 24 months after the accident with followed data collection :

Clinical, neuropsychological assessments
Diffusion magnetic resonance imaging (MRI) for the reconstruction of anatomical pathways
Functional imaging data.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Traumatic brain injury population		Defined population : traumatic brain injury population	Other: Cognitive rehabilitation program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive rehabilitation program	Other	Rehabilitation	Traumatic brain injury population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Baseline standardized volume of the white matter fascicles	determined on the "iplan" software. Baseline measured at 3 months after brain traumatic injury.	at 3, 12 and 24 months

Secondary Outcomes

Measure	Description	Time Frame
Measure of the volume of activations clusters	during functional MRI for attention, motor, working memory, language tasks.	at 3, 12 and 24 months
Location of activation clusters	during functional MRI for attention, motor, working memory, language tasks.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients, over the age of 18.
Mild traumatic brain injury (Initial Glasgow score between 9 and 12)
Severe brain injury (Initial Glasgow score between 3 and 8),
Diffuse axonal injury and/or focal lesions.

Exclusion Criteria:

Patients with MRI contraindications,
Antecedents of brain lesions,
Important lesions of the lobes and cortex on cerebral CT,
Anoxic lesions related to cardiorespiratory arrest,
Must be able to perform neuropsychological tests,
Visual and auditory impairments.
Aphasia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients with traumatic brain injury

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand		Clermont-Ferrand	Auvergne	63003	France

Condition Browse Module

MeSH Terms

ID	Term
D006259	Craniocerebral Trauma
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries
D008228	Lymphoma, Non-Hodgkin

Browse Leaves

Not provided

Browse Branches

Not provided