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
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Andreas Meisel, MD Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
  More Information

No publications provided

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
Study First Received: July 8, 2011
Last Updated: February 11, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Stroke
Perceptual Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014