Hemispatial NeglectAtNetNCT02467114
Interactions Between Attentional Networks and Their Influence on Perception
A study testing Transcranial magnetic stimulation (TMS) in people with Hemispatial Neglect, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemispatial Neglect
- What is being tested?
- Transcranial magnetic stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
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
About this study
Official title: Interactions Between Attentional Networks and Their Influence on Perception: a Project in Healthy Subjects and Hemispatial Neglect Patients
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.
Read the 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.
- Conditions
- Hemispatial Neglect
- Being tested
- Transcranial magnetic stimulation (TMS), Sham coil stimulation, Control without stimulation
- Medical subject headings
- Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation (TMS)Device
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
Sham coil stimulationDevice
Stimulation with a sham coil as a comparison
Control without stimulationOther
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Experimental | Stimulation with TMS, a sham coil \& no intervention Receives: Device: Transcranial magnetic stimulation (TMS); Device: Sham coil stimulation; Other: Control without stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical excitability, as measured by motor evoked potentials (MEPs)
Measured: During or within 1 hour after application
Spatial attentional performance, as measured by cognitive testing
Measured: During or within 1 hour after application
Number of perceptual switches
Measured: During or within 1 hour after application
Duration of dominance phases of perceptual switches
Measured in seconds
Measured: During or within 1 hour after application
Secondary outcomes (4)
Alertness level, as measured subjectively by a visual analogue scale (VAS)
Measured: During or 1 hour after application
Alertness level, as measured objectively by cognitive testing
Measured: During or 1 hour after application
Spatial bias of attentional allocation, as measured by standardised paper-pencil neuropsychological tests
Measured: During or 1 hour after application
Spatial bias of attentional allocation, as measured by free visual exploration with eye movement measurement
Measured: During or 1 hour after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hemispatial NeglectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Luzerner Kantonsspital
- Responsible party
- Sponsor
- Investigators
- René M. Müri, Prof. Dr. med., Principal investigator, Department of Neurology, Inselspital, Bern University HospitalThomas Nyffeler, Prof. Dr. med., Principal investigator, Center for Neurology and Neurorehabilitation, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467114
- Sponsor's protocol ID
- 036/15
- Acronym
- AtNet
- Status last verified
- Nov 2020
- First submitted
- 27 May 2015
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18466742Corbetta 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.
PubMed 11994752Corbetta M, Shulman GL. Spatial neglect and attention networks. Annu Rev Neurosci. 2011;34:569-99. doi: 10.1146/annurev-neuro-061010-113731.
PubMed 21692662Koch 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.
PubMed 18948300Sack 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.
PubMed 20714073
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions Between Attentional Networks and Their Influence on Perception: a Project in Healthy Subjects and Hemispatial Neglect Patients
- ClinicalTrials.gov ID
- NCT02467114
- Acronym / sponsor ID
- AtNet / 036/15
- Conditions
- Hemispatial Neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern, Luzerner Kantonsspital
- Study start
- Jun 2015 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | Experimental | Device: Transcranial magnetic stimulation (TMS), Device: Sham coil stimulation, Other: Control without stimulationStimulation with TMS, a sham coil \& no intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulation (TMS)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 | Device | All study participants |
| Sham coil stimulationStimulation with a sham coil as a comparison | Device | All study participants |
| Control without stimulation | Other | All study participants |
Primary outcome
Cortical excitability, as measured by motor evoked potentials (MEPs)
Time frame: During or within 1 hour after application
Spatial attentional performance, as measured by cognitive testing
Time frame: During or within 1 hour after application
Number of perceptual switches
Time frame: During or within 1 hour after application
Duration of dominance phases of perceptual switches
Time frame: During or within 1 hour after application
Measured in seconds
4 secondary outcomes
Alertness level, as measured subjectively by a visual analogue scale (VAS)
Time frame: During or 1 hour after application
Alertness level, as measured objectively by cognitive testing
Time frame: During or 1 hour after application
Spatial bias of attentional allocation, as measured by standardised paper-pencil neuropsychological tests
Time frame: During or 1 hour after application
Spatial bias of attentional allocation, as measured by free visual exploration with eye movement measurement
Time frame: During or 1 hour after application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Background: PubMed 18466742Corbetta 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.
- Background: PubMed 11994752Corbetta 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.
- Background: PubMed 21692662Corbetta M, Shulman GL. Spatial neglect and attention networks. Annu Rev Neurosci. 2011;34:569-99. doi: 10.1146/annurev-neuro-061010-113731.
- Background: PubMed 18948300Koch 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.
- Background: PubMed 20714073Sack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René M. Müri, Prof. Dr. med. principal investigator
Department of Neurology, Inselspital, Bern University Hospital
Thomas Nyffeler, Prof. Dr. med. principal investigator
Center for Neurology and Neurorehabilitation, Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation (TMS) in people with Hemispatial Neglect, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical excitability, as measured by motor evoked potentials (MEPs) (time frame: During or within 1 hour after application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02467114, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.