NCT00715806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 23, 2011

Status Verified

November 1, 2009

Enrollment Period

1.2 years

First QC Date

July 10, 2008

Last Update Submit

June 21, 2011

Conditions

Claustrophobia

Keywords

claustrophobiamagnetic resonance imagingMRIanxietyopen designseverely anxious patients

Outcome Measures

Primary Outcomes (1)

  • The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations.

    Before or During MRI

Secondary Outcomes (1)

  • Impact of MR imaging results on subsequent measurement.

    6 months after MRI

Study Arms (2)

1

EXPERIMENTAL
Device: Open MRI scanner.

2

ACTIVE COMPARATOR
Device: Closed MRI scanner.

Interventions

Open MRI scanner.DEVICE

Imaging in an Open MRI scanner.

1
Closed MRI scanner.DEVICE

Imaging in a short-bore closed MRI scanner.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (5)

  • 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.

    PMID: 17969166BACKGROUND

  • 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.

    PMID: 17383136BACKGROUND

  • Enders J, Zimmermann E, Rief M, Martus P, Klingebiel R, Asbach P, Klessen C, Diederichs G, Bengner T, Teichgraber U, Hamm B, Dewey M. Reduction of claustrophobia during magnetic resonance imaging: methods and design of the "CLAUSTRO" randomized controlled trial. BMC Med Imaging. 2011 Feb 10;11:4. doi: 10.1186/1471-2342-11-4.

    PMID: 21310075BACKGROUND

  • Enders J, Rief M, Zimmermann E, Asbach P, Diederichs G, Wetz C, Siebert E, Wagner M, Hamm B, Dewey M. High-field open versus short-bore magnetic resonance imaging of the spine: a randomized controlled comparison of image quality. PLoS One. 2013 Dec 31;8(12):e83427. doi: 10.1371/journal.pone.0083427. eCollection 2013.

    PMID: 24391767DERIVED

  • Enders J, Zimmermann E, Rief M, Martus P, Klingebiel R, Asbach P, Klessen C, Diederichs G, Wagner M, Teichgraber U, Bengner T, Hamm B, Dewey M. Reduction of claustrophobia with short-bore versus open magnetic resonance imaging: a randomized controlled trial. PLoS One. 2011;6(8):e23494. doi: 10.1371/journal.pone.0023494. Epub 2011 Aug 22.

    PMID: 21887259DERIVED

MeSH Terms

Conditions

ClaustrophobiaAnxiety Disorders

Condition Hierarchy (Ancestors)

Phobic DisordersMental Disorders

Study Officials

  • Marc Dewey, MD

    Charité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 15, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

June 23, 2011

Record last verified: 2009-11

Locations

DE(1)