Virtual Reality for Neglect Diagnostics (KMS-Neglect)

This study has been completed.

Sponsor:

Collaborators:

Median Klinik Kladow

Freie Universität Berlin

Berlin Center for Advanced Neuroimaging

Berlin School of Mind and Brain - Humboldt-Universität zu Berlin

Information provided by (Responsible Party):

Andreas Meisel, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01399073

First received: July 8, 2011

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2011

Last Updated Date

February 11, 2013

Start Date ^ICMJE

May 2011

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feasibility [ Time Frame: within the first 2 years after stroke ] [ Designated as safety issue: No ]

Feasibility of the use of a virtual reality setup in the diagnostics of neglect

Original Primary Outcome Measures ^ICMJE

Feasibility [ Time Frame: within the first 2 years after stroke ] [ Designated as safety issue: No ]

Feasibilty of the use of a virtual reality setup in the diagnostics of neglect

Change History

Complete list of historical versions of study NCT01399073 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sensitivity and Specificity [ Time Frame: within the first 2 years after stroke ] [ Designated as safety issue: No ]
The diagnostics of neglect via a virtual reality setup is more sensitive and more specific than the standard diagnostics via "paper-and-pencil" Tests
mri (functional (resting state) and structural imaging [ Time Frame: within the first 2 years after stroke ] [ Designated as safety issue: No ]
We hypothesize that there are connectivity-based differences in the different stages of neglect and anatomical and functional connectivity correlates with respect to behavioural impairment.

Original Secondary Outcome Measures ^ICMJE

Sensitivity and Specificity [ Time Frame: within the first 2 years after stroke ] [ Designated as safety issue: No ]

The diagnostics of neglect via a virtual reality setup is more sensitive and more specific than the standard diagnostics via "paper-and-pencil" Tests

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Virtual Reality for Neglect Diagnostics

Official Title ^ICMJE

Virtual Reality for Neglect Diagnostics

Brief Summary

Compared to the classical "paper and pencil"-tests, testing patients in our virtual reality setup might have a higher sensitivity and specificity.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients with acute (< 2 wks after stroke), subacute (2 wks- 3 months after stroke)or chronic (3- 24 months after stroke)stroke with neglect or hemianopsia.

Healthy, age-matched controls.

Condition ^ICMJE

Spatial Neglect
Stroke

Intervention ^ICMJE

Behavioral: virtual reality setup
testing for neglect in a virtual reality setup
Behavioral: paper and pencil tests
testing for neglect with the classical paper-and-pencil tests
Other: c-mri
structural and functional (resting state) imaging

Study Group/Cohort (s)

Patients with Neglect
Interventions:
- Behavioral: virtual reality setup
- Behavioral: paper and pencil tests
- Other: c-mri
Patients with Hemianopsia
Interventions:
- Behavioral: virtual reality setup
- Behavioral: paper and pencil tests
- Other: c-mri
Healthy age-matched controls
Interventions:
- Behavioral: virtual reality setup
- Behavioral: paper and pencil tests
- Other: c-mri

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2012

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria for neglect patients:

age ≥18 and <80 years
first stroke
neglect symptoms
no hemianopsia symptoms
consent given by the patient

Inclusion Criteria for hemianopsia patients:

age ≥18 and <80 years
first stroke
no neglect symptoms
hemianopsia symptoms
consent given by the patient

Inclusion Criteria for Controls:

age ≥18 and <80 years
no neurological deficits
informed consent

Exclusion Criteria (for all groups):

language comprehension deficits
motor deficits of the upper extremities
cognitive impairments (MMSE <20 or SKT >15 or DEMTEC >12)
depression
seizure disorders
claustrophobia

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01399073

Other Study ID Numbers ^ICMJE

KMS-Neglect

Has Data Monitoring Committee

Responsible Party

Andreas Meisel, Charite University, Berlin, Germany

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Median Klinik Kladow
Freie Universität Berlin
Berlin Center for Advanced Neuroimaging
Berlin School of Mind and Brain - Humboldt-Universität zu Berlin

Investigators ^ICMJE

Principal Investigator:

Andreas Meisel, MD

Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)

Information Provided By

Charite University, Berlin, Germany

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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