MR Compatible Accelerometer for Respiratory MOTion Measurement

NCT02894632 | Completed

• 1 other identifier: 2012-A00874-39
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A novel magnetic resonance (MR) compatible accelerometer for respiratory motion sensing (MARMOT) has been developed as a surrogate of the vendors' pneumatic belts. The aim is to model and correct respiratory motion for free-breathing thoracic-abdominal MR imaging and to simplify patient installation.

Conditions

Heart Disease

Keywords

MRI; Motion; Respiratory movement; Artifacts correction

Outcome Measures

Primary Outcomes (3)

• Respiratory movement using respiratory belts

  Respiratory belts, which are usually used in MRI to monitor respiratory movements and brath-holding, are placed around the volunteer's body (on the abdominal and on the thoracic level). They give the average displacement (in mm) across time generated by the respiratory movement.

  four months

• Respiratory movement using MARMOT sensors

  MARMOT sensors are placed on the volunteer's body (4 sensors placed on the thorax or on the abdomen). MARMOT sensors give 2 measures : acceleration generated by the respiratory movement (in mm/s²) in 3 directions and rotation generated by the respiratory movement (angle in °/s) in 3 directions.

  four months

• Respiratory movement using real-time MR images

  Motion measurement (in mm) directly on the MR images (using real-time MR imaging)

  four months

Secondary Outcomes (1)

• Subjective quality (marks between 1 (the best) and 3 (the worst) of the reconstructed MR images)

  four months

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Volunteers without cardiac, hepatic or renal pathology

Device: MRI compatible motion sensor (MARMOT)

Interventions

MRI compatible motion sensor (MARMOT) DEVICE

MRI with motion control (several motion sensors placed on the volunteer's body)

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To not have cardiac, hepatic or renal pathology
• To be more than 18
• To be enrolled in a social security plan
• To have signed an informed consent
• To have preliminary medical examination

You may not qualify if:

• Contraindication: implantable devices (pacemakers, defibrillators, cochlear implants, etc.), metallic foreign bodies
• Impossibility to undergo MRI : claustrophobia, morbid obesity
• Pregnancy or risk of pregnancy
• Patient under a measure of legal protection

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Laurent Bonnemains, Dr

  Inserm - U947

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 9, 2016
• Study Start: July 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 9, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)