Exploring Medical Decisions Using Functional MRI | NCT02994004

Studies
Exploring Medical Decisions Using Functional MRI

NCT02994004

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Dec 15, 2016Estimated

Enrollment

34Actual

Phase

Not provided

Conditions

F-MRI Brain Imaging Data

Interventions

no intervention

Countries

Not provided

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

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2015Actual

First Submitted Date

Sep 5, 2016

First Submission Date that Met QC Criteria

Dec 13, 2016

First Posted Date

Dec 15, 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

Dec 13, 2016

Last Update Posted Date

Dec 15, 2016Estimated

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

Hospital physicians are increasingly facing budgetary constraints that might have an impact on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might translate into role conflict and ambiguity. We explore the medical decision-makingprocess of physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated medical decisions during fMRI acquisitions, with and without explicit budgetary constraints. We will compare the fMRI data between the 2 modalities.

Detailed Description

Not provided

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

34Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain activation patterns measured by Functional magnetic resonance imaging		up to study completion, usually 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Level of role conflict, measured by the Kahn questionnaire (Kahn et al., 1964)		up tu study completion, usually 2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospital physicians
working in the CHU of Montpellier

Exclusion Criteria:

Contra indication to f-MRI

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Hospital physicians

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregoire MERCIER, MD, PhD	University Montpellier Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided