NCT02467114

Brief Summary

Attention can be defined as the preparedness to rapidly and accurately respond to stimuli coming from the investigators environment and to effectively select between relevant and irrelevant information. According to a current model, visual attentional control is based on two separate groups of brain regions, so called brain networks. These networks control different attentional aspects (e.g., spatial/non-spatial attention) and they interact with each other. A disruption of these interactions can lead to attentional disorders such as hemispatial neglect. Patients with hemispatial neglect have difficulties directing their attention to the left visual field and they act as though the latter does not exist. To date, the interactions between the two attentional networks are poorly understood. The aim of this study consists in further clarifying different aspects of these interactions and their influence on visual perception in healthy participants and in patients with hemispatial neglect. Transcranial magnetic stimulation (TMS) will be the principal method applied in this study. TMS is a painless and non-invasive method, with which the activity of brain areas can be influenced temporarily. This allows us to draw conclusions regarding the functions and interactions of these brain areas. This study is designed to have a significant impact on the basic understanding of attentional control in the human brain and it can benefit the comprehension and treatment of attentional disorders, such as hemispatial neglect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

4.7 years

First QC Date

May 27, 2015

Last Update Submit

November 17, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Cortical excitability, as measured by motor evoked potentials (MEPs)

    During or within 1 hour after application

  • Spatial attentional performance, as measured by cognitive testing

    During or within 1 hour after application

  • Number of perceptual switches

    During or within 1 hour after application

  • Duration of dominance phases of perceptual switches

    Measured in seconds

    During or within 1 hour after application

Secondary Outcomes (4)

  • Alertness level, as measured subjectively by a visual analogue scale (VAS)

    During or 1 hour after application

  • Alertness level, as measured objectively by cognitive testing

    During or 1 hour after application

  • Spatial bias of attentional allocation, as measured by standardised paper-pencil neuropsychological tests

    During or 1 hour after application

  • Spatial bias of attentional allocation, as measured by free visual exploration with eye movement measurement

    During or 1 hour after application

Study Arms (1)

All study participants

EXPERIMENTAL

Stimulation with TMS, a sham coil \& no intervention

Device: Transcranial magnetic stimulation (TMS)Device: Sham coil stimulationOther: Control without stimulation

Interventions

This method will be applied to measure cortical excitability and as an interference approach; real TMS stimulation will be compared with sham stimulation and no stimulation

All study participants

Stimulation with a sham coil as a comparison

All study participants
All study participants

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Healthy participants:
  • Age 18-80 years
  • Neurologically healthy, i.e., with no documented or present neurological disease or brain injury
  • normal or corrected-to-normal visual acuity
  • Patients:
  • Age 18-80 years
  • Showing signs of left hemispatial neglect after a right-hemispheric brain lesion, as assessed by previous neuropsychological testing and clinical judgment
  • Normal or corrected-to-normal visual acuity

You may not qualify if:

  • Healthy participants:
  • Any instable medical condition, in particular epilepsy (past or present, including seizures or febrile convulsions)
  • Any surgical intervention to the brain
  • Implanted medical devices (e.g., cochlear implants, infusion pumps, neurostimulators, pacemakers)
  • Presence of metal in the region of the head (excluding fixed dental implants such as tooth fillings or fixed dental braces)
  • Drug or alcohol abuse
  • Intake of any medication that is likely to lower seizure threshold
  • For female participants: pregnancy or breast feeding or intention to become pregnant during the course of the experiment. All participants of childbearing potential will be asked to take a pregnancy test.
  • Patients:
  • Any instable medical condition, in particular epilepsy (past or present, including seizures or febrile convulsions)
  • Implanted medical devices (e.g., cochlear implants, infusion pumps, neurostimulators, pacemakers)
  • Presence of metal in the region of the head (excluding fixed dental implants such as tooth fillings or fixed dental braces)
  • Drug or alcohol abuse
  • Intake of any medication that is likely to lower seizure threshold
  • For female participants: pregnancy or breast feeding or intention to become pregnant during the course of the experiment. All participants of childbearing potential will be asked to take a pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cognitive and Restorative Neurology, Department of Neurology, Inselspital, Bern University Hospital; Gerontechnology and Rehabilitation Group, ARTORG Center for Biomedical Engineering Research, University of Bern

Bern, 3010, Switzerland

Location

Related Publications (5)

  • Corbetta M, Patel G, Shulman GL. The reorienting system of the human brain: from environment to theory of mind. Neuron. 2008 May 8;58(3):306-24. doi: 10.1016/j.neuron.2008.04.017.

    PMID: 18466742BACKGROUND
  • Corbetta M, Shulman GL. Control of goal-directed and stimulus-driven attention in the brain. Nat Rev Neurosci. 2002 Mar;3(3):201-15. doi: 10.1038/nrn755.

    PMID: 11994752BACKGROUND
  • Corbetta M, Shulman GL. Spatial neglect and attention networks. Annu Rev Neurosci. 2011;34:569-99. doi: 10.1146/annurev-neuro-061010-113731.

    PMID: 21692662BACKGROUND
  • Koch G, Oliveri M, Cheeran B, Ruge D, Lo Gerfo E, Salerno S, Torriero S, Marconi B, Mori F, Driver J, Rothwell JC, Caltagirone C. Hyperexcitability of parietal-motor functional connections in the intact left-hemisphere of patients with neglect. Brain. 2008 Dec;131(Pt 12):3147-55. doi: 10.1093/brain/awn273. Epub 2008 Oct 22.

    PMID: 18948300BACKGROUND
  • Sack AT. Using non-invasive brain interference as a tool for mimicking spatial neglect in healthy volunteers. Restor Neurol Neurosci. 2010;28(4):485-97. doi: 10.3233/RNN-2010-0568.

    PMID: 20714073BACKGROUND

MeSH Terms

Conditions

Perceptual Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • René M. Müri, Prof. Dr. med.

    Department of Neurology, Inselspital, Bern University Hospital

    PRINCIPAL INVESTIGATOR
  • Thomas Nyffeler, Prof. Dr. med.

    Center for Neurology and Neurorehabilitation, Luzerner Kantonsspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2015

First Posted

June 9, 2015

Study Start

June 1, 2015

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations