Virtual Reality for Neglect Diagnostics (KMS-Neglect)

November 28, 2018 updated by: Andreas Meisel, Charite University, Berlin, Germany
Compared to the classical "paper and pencil"-tests, testing patients in our virtual reality setup might have a higher sensitivity and specificity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité University Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: within the first 2 years after stroke
Feasibility of the use of a virtual reality setup in the diagnostics of neglect
within the first 2 years after stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the first 2 years after stroke
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.
within the first 2 years after stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Freie Universität Berlin
NeuroCure Clinical Research Center, Charite, Berlin
Humboldt-Universität zu Berlin
Median Klinik Kladow
Berlin Center for Advanced Neuroimaging

Investigators

  • Principal Investigator: Andreas Meisel, MD, Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 21, 2011

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMS-Neglect

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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