NCT01740544

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

July 27, 2012

Last Update Submit

November 28, 2018

Conditions

Visual Neglect

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

  • Test performance of study participants in the Test Battery for Attention Performance (TAP) with/without cathodal stimulation

  • Comparison of visual search patterns between neglect patients and healthy subjects with cathodal stimulation

Study Arms (4)

Cathodal tDCS in young study participants

EXPERIMENTAL

Cathodal tDCS in young study participants

Other: Cathodal tDCS

Cathodal tDCS in elderly study participants

EXPERIMENTAL

Cathodal tDCS in elderly study participants

Other: Cathodal tDCS

Sham tDCS in young study participants

SHAM COMPARATOR

Sham tDCS in young study participants

Other: Sham tDCS

Sham tDCS in elderly study participants

SHAM COMPARATOR

Sham tDCS in elderly study participants

Other: Sham tDCS

Interventions

Cathodal tDCSOTHER

Cathodal tDCS applied over the right PPC

Cathodal tDCS in elderly study participantsCathodal tDCS in young study participants
Sham tDCSOTHER

Sham tDCS applied over the right PPC

Sham tDCS in elderly study participantsSham tDCS in young study participants

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Medicine

Berlin, 10117, Germany

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Andreas Meisel, MD

    Charite - Universitätsmedizin Berlin (NeuroCure Clinical Research Center)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Andreas Meisel

Study Record Dates

First Submitted

July 27, 2012

First Posted

December 4, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 29, 2018

Record last verified: 2018-11

Locations

DE(1)