Claustrophobia and Magnetic Resonance Imaging | NCT00715806

Studies
Claustrophobia and Magnetic Resonance Imaging

NCT00715806

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

174Estimated

Phase

Not Applicable

Conditions

Claustrophobia

Interventions

Open MRI scanner.
Closed MRI scanner.

Countries

Germany

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

Nov 2009

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 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jul 10, 2008

First Submission Date that Met QC Criteria

Jul 11, 2008

First Posted Date

Jul 15, 2008Estimated

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 21, 2011

Last Update Posted Date

Jun 23, 2011Estimated

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

The objective of the study is to determine the ability of open magnetic resonance imaging (MRI) scanners to reduce claustrophobic reactions, thereby enabling more examinations of severely anxious patients. The investigators hypothesize that anxiety-based claustrophobia that prevents MR examinations without sedation can be reduced using an open MR scanner design thereby improving clinical management of those patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

174Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Device: Open MRI scanner.
2	Active Comparator		Device: Closed MRI scanner.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Open MRI scanner.	Device	Imaging in an Open MRI scanner.	1
Closed MRI scanner.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations.		Before or During MRI

Secondary Outcomes

Measure	Description	Time Frame
Impact of MR imaging results on subsequent measurement.		6 months after MRI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severely anxious patients with reported claustrophobia during MRI or with the inability to undergo MR examinations on conventional scanners
Clinical indication for MR imaging of the head, spine, or shoulder.

Exclusion Criteria:

Contraindication to MR imaging (shrapnells, pacemakers, certain unsafe implants)
Age below 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Dewey, MD	Charité	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité		Berlin	State of Berlin	10117	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17969166	Background	Dewey M, Schink T, Dewey CF. Claustrophobia during magnetic resonance imaging: cohort study in over 55,000 patients. J Magn Reson Imaging. 2007 Nov;26(5):1322-7. doi: 10.1002/jmri.21147.
17383136	Background	Dewey M, Schink T, Dewey CF. Frequency of referral of patients with safety-related contraindications to magnetic resonance imaging. Eur J Radiol. 2007 Jul;63(1):124-7. doi: 10.1016/j.ejrad.2007.01.025. Epub 2007 Mar 23.

ID	Term
D000098452	Claustrophobia
D001008	Anxiety Disorders

ID	Term
D010698	Phobic Disorders
D001523	Mental Disorders