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

NCT02544386 | Terminated

• 2 other identifiers: 07011162008-A00048-47
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Hemiplegia

Keywords

bone microarchitecture; hemiplegia

Outcome Measures

Primary Outcomes (1)

• Bone volume / tissue volume

  Measure of Bone volume / tissue volume by the 3D CT scan

  90 days

Secondary Outcomes (2)

• Bone volume / tissue volume

  1 day

• intraosseous fat

  90 days

Study Arms (1)

Patients

Patients who have experienced a vascular hemiplegia and accept bone measure by MRI and 3D CT scan

Procedure: MRI and 3D CT scan

Interventions

MRI and 3D CT scan PROCEDURE

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)

Patients

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient aged at least 30 who have experienced a vascular hemiplegia within 30 days before enrollment

You may qualify if:

• 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

You may not qualify if:

• Concomitant bone disease
• Endocrinopathies
• Phasic disorders understanding
• Contra-indication to MRI

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Thierry THOMAS, MD-PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 9, 2015
• Study Start: June 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 9, 2015

Record last verified: 2015-09