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

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.

Study Overview

• Status: Terminated
• Conditions: Visual Neglect
• Intervention / Treatment: Other: Cathodal tDCS; Other: Sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite University Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cathodal tDCS in young study participants	Other: Cathodal tDCS; Cathodal tDCS applied over the right PPC
Experimental: Cathodal tDCS in elderly study participants	Other: Cathodal tDCS; Cathodal tDCS applied over the right PPC
Sham Comparator: Sham tDCS in young study participants	Other: Sham tDCS; Sham tDCS applied over the right PPC
Sham Comparator: Sham tDCS in elderly study participants	Other: Sham tDCS; Sham tDCS applied over the right PPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Test performance of young study participants in the encircling monitor system with/without cathodal stimulation

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

Outcome Measure	Measure Description
Test performance of elderly study participants in the encircling monitor system with/without cathodal stimulation	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	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	Comparison of visual search direction, structuredness (crossing index), and omissions in the Star Cancellation Test

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: NeuroCure Clinical Research Center, Charite, Berlin; Humboldt-Universität zu Berlin; Center for Stroke Research Berlin; Median Klinik Berlin-Kladow; Free University of Berlin
• Investigators: Principal Investigator: Andreas Meisel, MD, Charite - Universitätsmedizin Berlin (NeuroCure Clinical Research Center)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 27, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (Estimate): December 4, 2012

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

• Other Study ID Numbers: KMS-Neglect 2