Computerised Assessment of Visual Neglect Symptoms in Peripersonal Space (KMS-Neglect 2)

This study has been completed.
Sponsor:
Collaborators:
Median Klinik Berlin-Kladow
Center for Stroke Research Berlin
Free University of Berlin
Humboldt-Universität zu Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01740544
First received: July 27, 2012
Last updated: September 26, 2013
Last verified: September 2013

July 27, 2012
September 26, 2013
October 2012
December 2012   (final data collection date for primary outcome measure)
Test performance of young study participants in the encircling monitor system with/without cathodal stimulation [ Time Frame: n.a. ] [ Designated as safety issue: No ]
Comparison of the young subjects' performance with vs. without transcranial direct current stimulation (tDCS) in the following computerised tests: Star Cancellation (number of omissions, latency & crossing index; based on Rabufetti, 2012), Landmark (reaction times, accuracy; based on Giglia et al., 2011), Visual Detection (reaction times, omissions; based on Sparing et al., 2009), Extinction (number of correct responses; based on Niedeggen & Hoffmann, 2011)
Test performance of young study participants in the encircling monitor system with/without cathodal stimulation [ Time Frame: n.a. ] [ Designated as safety issue: No ]
Comparison of the young subjects' performance with vs. without tDCS in the following computerised tests: Star Cancellation (number of omissions, latency & crossing index; based on Rabufetti, 2012), Landmark (reaction times, accuracy; based on Giglia et al., 2011) , Visual Detection (reaction times, omissions; based on Sparing et al., 2009), Extinction (number of correct responses; based on Niedeggen & Hoffmann, 2011)
Complete list of historical versions of study NCT01740544 on ClinicalTrials.gov Archive Site
  • Test performance of elderly study participants in the encircling monitor system with/without cathodal stimulation [ Time Frame: n.a. ] [ Designated as safety issue: No ]
    Comparison of the performance with vs. without transcranial direct current stimulation (tDCS) in the following tests: Star Cancellation, Landmark, Visual Detection, Extinction (see above)
  • Test performance of study participants in the Test Battery for Attention Performance (TAP) with/without cathodal stimulation [ Time Frame: n.a. ] [ Designated as safety issue: No ]
    Comparison of reaction times and number of omissions in the left and right visual field in the TAP subtest "Neglect" with vs. without tDCS.
  • Comparison of visual search patterns between neglect patients and healthy subjects with cathodal stimulation [ Time Frame: n.a. ] [ Designated as safety issue: No ]
    Comparison of visual search direction, structuredness (crossing index), and omissions in the Star Cancellation Test
  • Test performance of elderly study participants in the encircling monitor system with/without cathodal stimulation [ Time Frame: n.a. ] [ Designated as safety issue: No ]
    Comparison of the performance with vs. without tDCS in the following tests: Star Cancellation, Landmark , Visual Detection, Extinction (see above)
  • Test performance of study participants in the Test Battery for Attention Performance(TAP) with/without cathodal stimulation [ Time Frame: n.a. ] [ Designated as safety issue: No ]
    Comparison of reaction times and number of omissions in the left and right visual field in the TAP subtest "Neglect" with vs. without tDCS.
  • Comparison of visual search patterns between neglect patients and healthy subjects with cathodal stimulation [ Time Frame: n.a. ] [ Designated as safety issue: No ]
    Comparison of visual search direction, structuredness (crossing index), and omissions in the Star Cancellation Test
Not Provided
Not Provided
 
Computerised Assessment of Visual Neglect Symptoms in Peripersonal Space
Computerised Assessment of Visual Neglect Symptoms in Peripersonal Space

Healthy subjects will undergo cathodal stimulation of the right posterior parietal Cortex (PPC) and assessment of neglect-like symptoms in the encircling monitor system (EMS) as well as in a standard clinical test (Test Battery for Attention Performance, TAP, Zimmermann & Fimm, 1993). The aim of this study is to investigate whether cathodal stimulation leads to poorer test performance.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Visual Neglect
  • Other: Cathodal tDCS
    Cathodal tDCS applied over the right PPC
  • Other: Sham tDCS
    Sham tDCS applied over the right PPC
  • Experimental: Cathodal tDCS in young study participants
    Cathodal tDCS in young study participants
    Intervention: Other: Cathodal tDCS
  • Experimental: Cathodal tDCS in elderly study participants
    Cathodal tDCS in elderly study participants
    Intervention: Other: Cathodal tDCS
  • Sham Comparator: Sham tDCS in young study participants
    Sham tDCS in young study participants
    Intervention: Other: Sham tDCS
  • Sham Comparator: Sham tDCS in elderly study participants
    Sham tDCS in elderly study participants
    Intervention: Other: Sham tDCS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Younger subjects

    • aged between 18 and 35 years
    • ability to provide written informed consent
    • right-handedness
  • Elderly subjects

    • aged between 50 and 85 years
    • ability to provide written informed consent
    • right-handedness

Exclusion Criteria:

- Exclusion criteria for both groups:

  • serious psychiatric disorders (including depression, psychosis) in the past
  • severe neurological disorders (such as epilepsy, dementia, stroke) in the past
  • current severe medical disorder
  • drugs, medication or alcohol abuse at the time of the study
  • severe traumatic brain injury or tumor in the past
  • operations on the brain, trepanations
  • metallic implants in the head / neck area (except in the mouth), such as screws, splinter, artificial cochlea, electrodes
  • severe skin diseases (like eczema) or very sensitive skin in the head region in the past
  • epilepsy in the family
  • current use of neuroleptics, antiepileptics, antidepressants, L-dopa, benzo-diazepines
  • current pregnancy or lactation
  • current claustrophobia
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01740544
KMS-Neglect 2
No
Andreas Meisel, Charite University, Berlin, Germany
Charite University, Berlin, Germany
  • Median Klinik Berlin-Kladow
  • Center for Stroke Research Berlin
  • Free University of Berlin
  • Humboldt-Universität zu Berlin
Not Provided
Charite University, Berlin, Germany
September 2013

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