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Virtual Reality for Neglect Diagnostics (KMS-Neglect)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01399073
First Posted: July 21, 2011
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Median Klinik Kladow
Freie Universität Berlin
Berlin Center for Advanced Neuroimaging
Humboldt-Universität zu Berlin
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
  Purpose
Compared to the classical "paper and pencil"-tests, testing patients in our virtual reality setup might have a higher sensitivity and specificity.

Condition Intervention
Spatial Neglect Stroke Behavioral: virtual reality setup Behavioral: paper and pencil tests Other: c-mri

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Virtual Reality for Neglect Diagnostics

Further study details as provided by Andreas Meisel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Feasibility [ Time Frame: within the first 2 years after stroke ]
    Feasibility of the use of a virtual reality setup in the diagnostics of neglect


Secondary Outcome Measures:
  • Sensitivity and Specificity [ Time Frame: within the first 2 years after stroke ]
    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 ]
    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.


Enrollment: 27
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Neglect 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 Hemianopsia 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
Healthy age-matched controls 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399073


Locations
Germany
Charité University Medicine
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Median Klinik Kladow
Freie Universität Berlin
Berlin Center for Advanced Neuroimaging
Humboldt-Universität zu Berlin
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
Principal Investigator: Andreas Meisel, MD Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
  More Information

Responsible Party: Andreas Meisel, Prof. Dr. Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01399073     History of Changes
Other Study ID Numbers: KMS-Neglect
First Submitted: July 8, 2011
First Posted: July 21, 2011
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
stroke
neglect
hemianopsia
virtual reality