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
  Purpose

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.


Condition Intervention
Visual Neglect
Other: Cathodal tDCS
Other: Sham tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Computerised Assessment of Visual Neglect Symptoms in Peripersonal Space

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

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cathodal tDCS in young study participants
Cathodal tDCS in young study participants
Other: Cathodal tDCS
Cathodal tDCS applied over the right PPC
Experimental: Cathodal tDCS in elderly study participants
Cathodal tDCS in elderly study participants
Other: Cathodal tDCS
Cathodal tDCS applied over the right PPC
Sham Comparator: Sham tDCS in young study participants
Sham tDCS in young study participants
Other: Sham tDCS
Sham tDCS applied over the right PPC
Sham Comparator: Sham tDCS in elderly study participants
Sham tDCS in elderly study participants
Other: Sham tDCS
Sham tDCS applied over the right PPC

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01740544

Locations
Germany
Charité University Medicine
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Median Klinik Berlin-Kladow
Center for Stroke Research Berlin
Free University of Berlin
Humboldt-Universität zu Berlin
  More Information

No publications provided

Responsible Party: Andreas Meisel, Prof. Dr. med. Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01740544     History of Changes
Other Study ID Numbers: KMS-Neglect 2
Study First Received: July 27, 2012
Last Updated: September 26, 2013
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on August 21, 2014