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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
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

July 8, 2011
February 11, 2013
May 2011
July 2012   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01399073 on ClinicalTrials.gov Archive Site
  • 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.
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
Not Provided
Not Provided
 
Virtual Reality for Neglect Diagnostics
Virtual Reality for Neglect Diagnostics

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

  • Spatial Neglect
  • Stroke
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01399073
KMS-Neglect
No
Andreas Meisel, Charite University, Berlin, Germany
Charite University, Berlin, Germany
  • Median Klinik Kladow
  • Freie Universität Berlin
  • Berlin Center for Advanced Neuroimaging
  • Humboldt-Universität zu Berlin
Principal Investigator: Andreas Meisel, MD Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Charite University, Berlin, Germany
February 2013

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