Interactions Between Attentional Networks and Their Influence on Perception (AtNet)
Primary Purpose
Hemispatial Neglect
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Transcranial magnetic stimulation (TMS)
Sham coil stimulation
Control without stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Hemispatial Neglect
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria
- 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
Sites / Locations
- 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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All study participants
Arm Description
Stimulation with TMS, a sham coil & no intervention
Outcomes
Primary Outcome Measures
Cortical excitability, as measured by motor evoked potentials (MEPs)
Spatial attentional performance, as measured by cognitive testing
Number of perceptual switches
Duration of dominance phases of perceptual switches
Measured in seconds
Secondary Outcome Measures
Alertness level, as measured subjectively by a visual analogue scale (VAS)
Alertness level, as measured objectively by cognitive testing
Spatial bias of attentional allocation, as measured by standardised paper-pencil neuropsychological tests
Spatial bias of attentional allocation, as measured by free visual exploration with eye movement measurement
Full Information
NCT ID
NCT02467114
First Posted
May 27, 2015
Last Updated
November 17, 2020
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern, Luzerner Kantonsspital
1. Study Identification
Unique Protocol Identification Number
NCT02467114
Brief Title
Interactions Between Attentional Networks and Their Influence on Perception
Acronym
AtNet
Official Title
Interactions Between Attentional Networks and Their Influence on Perception: a Project in Healthy Subjects and Hemispatial Neglect Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern, Luzerner Kantonsspital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Background
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. Attention is a complex cognitive function based on multiple components. A recent model postulates that attentional control in the brain is based on two discrete neural networks. The ventral (temporo-parietal - ventral frontal) network controls non-spatial aspects of attention, such as alertness and vigilance, and stimulus detection and reorientation in both hemifields. This network is lateralized towards the right hemisphere and plays a role as a 'circuit-breaker'. The dorsal (superior parietal - dorsal frontal) network controls spatial attentional shifts, is largely top-down driven, and substantially overlaps with eye movement control. This network is not functionally lateralized, each hemisphere containing dynamic topographical maps of the contralateral space. Moreover, the dorsal networks of the two hemispheres compete to direct attention to the contralateral hemispace, thereby exerting reciprocal inhibition.
Hemispatial neglect - the failure to detect, orient, or respond to stimuli located in the contralesional side of space - has been interpreted in terms of pathological changes in the interaction between the two attentional networks. Neglect is very common after cerebral lesions of the right hemisphere, usually affecting the ventral attentional network. The structurally intact right dorsal network would thus receive a weakened input from the right ventral network. The ensuing imbalance in the inhibition between the dorsal networks of the two hemispheres would then result in the rightward bias in attentional allocation, typically observed in hemispatial neglect.
However, little is known regarding the interactions between ventral and dorsal attentional networks and their influence on perception, and the greatest part of the evidence has been acquired through correlational approaches. The aim of this study is to further elucidate different aspects of these interactions and to investigate their influence on spatial and non-spatial attentional performance and on visual perception.
Objective
A first objective consists in further elucidating how and through which anatomical structures the ventral and the dorsal attentional networks interact. A second objective concerns how the interplay of dorsal and ventral attentional networks influences visual perception, in particular in cases in which visual stimuli are ambiguous.
Methods
Transcranial magnetic stimulation (TMS) is the principal method applied in this study. TMS is a non-invasive, painless method which is able to influence cortical areas directing attention in an interference approach and to thus establish causal relationships. Furthermore, TMS, in combination with the measurement of motor evoked potentials (MEP), allows for the assessment of the excitability of cortico-cortical circuits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemispatial Neglect
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All study participants
Arm Type
Experimental
Arm Description
Stimulation with TMS, a sham coil & no intervention
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation (TMS)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham coil stimulation
Intervention Description
Stimulation with a sham coil as a comparison
Intervention Type
Other
Intervention Name(s)
Control without stimulation
Primary Outcome Measure Information:
Title
Cortical excitability, as measured by motor evoked potentials (MEPs)
Time Frame
During or within 1 hour after application
Title
Spatial attentional performance, as measured by cognitive testing
Time Frame
During or within 1 hour after application
Title
Number of perceptual switches
Time Frame
During or within 1 hour after application
Title
Duration of dominance phases of perceptual switches
Description
Measured in seconds
Time Frame
During or within 1 hour after application
Secondary Outcome Measure Information:
Title
Alertness level, as measured subjectively by a visual analogue scale (VAS)
Time Frame
During or 1 hour after application
Title
Alertness level, as measured objectively by cognitive testing
Time Frame
During or 1 hour after application
Title
Spatial bias of attentional allocation, as measured by standardised paper-pencil neuropsychological tests
Time Frame
During or 1 hour after application
Title
Spatial bias of attentional allocation, as measured by free visual exploration with eye movement measurement
Time Frame
During or 1 hour after application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
René M. Müri, Prof. Dr. med.
Organizational Affiliation
Department of Neurology, Inselspital, Bern University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Nyffeler, Prof. Dr. med.
Organizational Affiliation
Center for Neurology and Neurorehabilitation, Luzerner Kantonsspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
18466742
Citation
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.
Results Reference
background
PubMed Identifier
11994752
Citation
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.
Results Reference
background
PubMed Identifier
21692662
Citation
Corbetta M, Shulman GL. Spatial neglect and attention networks. Annu Rev Neurosci. 2011;34:569-99. doi: 10.1146/annurev-neuro-061010-113731.
Results Reference
background
PubMed Identifier
18948300
Citation
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.
Results Reference
background
PubMed Identifier
20714073
Citation
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.
Results Reference
background
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Interactions Between Attentional Networks and Their Influence on Perception
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