Hemispatial Neglect Clinical Trial
— AtNetOfficial title:
Interactions Between Attentional Networks and Their Influence on Perception: a Project in Healthy Subjects and Hemispatial Neglect Patients
NCT number | NCT02467114 |
Other study ID # | 036/15 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | February 2020 |
Verified date | November 2020 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 214 |
Est. completion date | February 2020 |
Est. primary completion date | February 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | 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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | Luzerner Kantonsspital, University of Bern |
Switzerland,
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. Review. — View 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. Review. — View Citation
Corbetta M, Shulman GL. Spatial neglect and attention networks. Annu Rev Neurosci. 2011;34:569-99. doi: 10.1146/annurev-neuro-061010-113731. Review. — View 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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cortical excitability, as measured by motor evoked potentials (MEPs) | During or within 1 hour after application | ||
Primary | Spatial attentional performance, as measured by cognitive testing | During or within 1 hour after application | ||
Primary | Number of perceptual switches | During or within 1 hour after application | ||
Primary | Duration of dominance phases of perceptual switches | Measured in seconds | During or within 1 hour after application | |
Secondary | Alertness level, as measured subjectively by a visual analogue scale (VAS) | During or 1 hour after application | ||
Secondary | Alertness level, as measured objectively by cognitive testing | During or 1 hour after application | ||
Secondary | Spatial bias of attentional allocation, as measured by standardised paper-pencil neuropsychological tests | During or 1 hour after application | ||
Secondary | Spatial bias of attentional allocation, as measured by free visual exploration with eye movement measurement | During or 1 hour after application |
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