ClaustrophobiaCLAUSTRONCT00715806
Claustrophobia and Magnetic Resonance Imaging
A study testing Open MRI scanner. and Closed MRI scanner. in people with Claustrophobia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Claustrophobia
- What is being tested?
- Open MRI scanner. and Closed MRI scanner.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindication to MR imaging (shrapnells, pacemakers, certain unsafe implants)
- Age below 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Claustrophobia During Magnetic Resonance Imaging: Randomized, Controlled Trial
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.
- Conditions
- Claustrophobia
- Being tested
- Open MRI scanner., Closed MRI scanner.
- Keywords
- claustrophobia, magnetic resonance imaging, MRI, anxiety, open design, severely anxious patients
- Medical subject headings
- Claustrophobia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open MRI scanner.Device
Imaging in an Open MRI scanner.
Closed MRI scanner.Device
Imaging in a short-bore closed MRI scanner.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Open MRI scanner. |
| 2 | Active comparator | Not described Receives: Device: Closed MRI scanner. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations.
Measured: Before or During MRI
Secondary outcomes (1)
Impact of MR imaging results on subsequent measurement.
Measured: 6 months after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ClaustrophobiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Marc Dewey, MD, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715806
- Sponsor's protocol ID
- EA1/020/08
- Acronym
- CLAUSTRO
- Status last verified
- Nov 2009
- First submitted
- 10 Jul 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17969166Dewey 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.
PubMed 17383136Enders 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.
PubMed 21310075Enders 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.
PubMed 24391767Enders 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.
PubMed 21887259
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Claustrophobia During Magnetic Resonance Imaging: Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00715806
- Acronym / sponsor ID
- CLAUSTRO / EA1/020/08
- Conditions
- Claustrophobia
- Keywords
- claustrophobia, magnetic resonance imaging, MRI, anxiety, open design, severely anxious patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Open MRI scanner. |
| 2 | Active comparator | Device: Closed MRI scanner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindication to MR imaging (shrapnells, pacemakers, certain unsafe implants)
- Age below 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open MRI scanner.Imaging in an Open MRI scanner. | Device | 1 |
| Closed MRI scanner.Imaging in a short-bore closed MRI scanner. | Device | 2 |
Primary outcome
The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations.
Time frame: Before or During MRI
1 secondary outcome
Impact of MR imaging results on subsequent measurement.
Time frame: 6 months after MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Background: PubMed 17969166Dewey 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.
- Background: PubMed 17383136Dewey 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.
- Background: PubMed 21310075Enders 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.
- Derived from this study: PubMed 24391767Enders 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.
- Derived from this study: PubMed 21887259Enders 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Dewey, MD principal investigator
Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open MRI scanner. and Closed MRI scanner. in people with Claustrophobia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations. (time frame: Before or During MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00715806, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.