Virtual Reality for Neglect Diagnostics

Stroke Clinical Trial

— KMS-Neglect  

Official title:

Virtual Reality for Neglect Diagnostics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399073
• Other study ID #: KMS-Neglect
• Status: Completed
• Start date: May 2011
• Est. completion date: July 2012

Study information

• Verified date: November 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spatial Neglect
• Stroke

Intervention

Behavioral:
• virtual reality setup
testing for neglect in a virtual reality setup
• paper and pencil tests
testing for neglect with the classical paper-and-pencil tests

Other:
• c-mri
structural and functional (resting state) imaging

Locations

Country	Name	City	State
Germany	Charité University Medicine	Berlin

Sponsors (6)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Berlin Center for Advanced Neuroimaging, Freie Universität Berlin, Humboldt-Universität zu Berlin, Median Klinik Kladow, NeuroCure Clinical Research Center, Charite, Berlin

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Ulm L, Wohlrapp D, Meinzer M, Steinicke R, Schatz A, Denzler P, Klehmet J, Dohle C, Niedeggen M, Meisel A, Winter Y. A circle-monitor for computerised assessment of visual neglect in peripersonal space. PLoS One. 2013 Dec 12;8(12):e82892. doi: 10.1371/jou — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Feasibility of the use of a virtual reality setup in the diagnostics of neglect	within the first 2 years after stroke
Secondary	Sensitivity and Specificity	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
Secondary	mri (functional (resting state) and structural imaging	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