Impact of Hemiplegia Due to Stroke on the Microarchitecture of the Bone

Stroke Clinical Trial

Official title:

Impact of Hemiplegia Due to Stroke on the Microarchitecture of the Bone: Evaluation Using Micro CT 3D High Resolution and by Magnetic Resonance Imaging (MRI)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02544386
• Other study ID #: 0701116
• Secondary ID: 2008-A00048-47
• Status: Terminated
• Phase: N/A
• First received: September 7, 2015
• Last updated: September 8, 2015
• Start date: June 2009
• Est. completion date: September 2013

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

In hemiplegic, there is very little data on the impact of neurological deficit on the microarchitecture independent of bone mineral density and composition of the bone marrow. Rare studies have shown the relationship between some micro-architectural parameters and severity of neurological deficit. There is no study in humans on the evolution of the parameters of the microarchitecture assessed by 3D micro-tomography in the early phase of the installation of neurological deficits after stroke, in terms of a bearing bone, tibia, that a non-load bearing bones, radius.

Description:

Each patient must answer several questionnaires about their calcium intake and its ability to perform everyday tasks. They will also have 3 blood samples (15 ml each time), 3 measure of bone by 3D micro-tomography and 2 MRI examination. These examinations and sampling will take place after 30 days after stroke onset (except for MRI) and again after three months and six months after the stroke (the same day as the medical follow-up visit).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion criteria

• at least 30 years

• vascular hemiplegia

• National Institute of Health Stroke Score equal 4 or greater with a motor of upper limb score greater than or equal 2 and a motor score of greater than or equal legs 2

Exclusion criteria

• Concomitant bone disease

• Endocrinopathies

• Phasic disorders understanding

• Contra-indication to MRI

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Procedure:
• MRI and 3D CT scan
Measurement of bone microarchitecture at the legs and wrists by 3D CT Scan and measuring the proportion of fat in the imaging leg bone (MRI)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone volume / tissue volume	Measure of Bone volume / tissue volume by the 3D CT scan	90 days	Yes
Secondary	Bone volume / tissue volume	Measure of Bone volume / tissue volume by the 3D CT scan	1 day	Yes
Secondary	intraosseous fat	Measure the percentage of the intraosseous fat by MRI	90 days	Yes