Stability of Attentional Networks Over Multiple Sessions of Computerized TaskNCT04033731
Assessment of Stability of Behavioral and Neural Measures of Attention Networks Across Multiple Sessions
An observational study of Stability of Attentional Networks Over Multiple Sessions of Computerized Task, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to learn more about the stability over multiple recording sessions of brainwave activity during a computerized task that measures different types of attention. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stability of Attentional Networks Over Multiple Sessions of Computerized Task
- What is being tested?
- Attention Network Task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2019to 8 Nov 2019
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Controls
Who may be able to join
- right-hand dominant
- Native English speakers
- with normal or corrected-to-normal vision
Who cannot join
- Not right-hand dominant
- Does not speak english as a native language
- No history of neurological disorder such as stroke, epilepsy or chronic seizure disorder, traumatic brain injury or concussion, psychiatric disorder such as schizophrenia, bipolar disorder, major depression or anxiety disorder, any psychiatric inpatient hospitalization for any of these disorders, or previously diagnosed learning disability
- Currently taking any prescribed medications for anxiety, depression, or seizures
- Alcohol use more than 3 days a week
Trial locations and contacts
1 site in 1 country.
United States1 site
College of Public Health and Health Professions, University of Florida
Gainesville, Florida, 32611
About this study
The purpose of this research study is to learn more about the stability over multiple recording sessions of brainwave activity during a computerized task that measures different types of attention.
Read the detailed description
Attention is the backbone of cognitive systems and is requisite for other cognitive processes vital to everyday functioning, such as memory, problem solving, language skills, and the cognitive control of behavior. Impairments in attention can result from a variety of factors, such as brain injury, and neurodegenerative and neurodevelopmental disorders, as well as various psychopathologies. A prominent multi-component model of visuospatial attention developed by Posner and colleagues conceptualizes visuospatial attention as an "organ system" comprised of three independent, yet interactive networks which include: 1) Alerting, the generation and maintenance of a vigilant state that facilitates the processing of an upcoming stimulus, 2) Orienting, the disengagement, shifting, and reallocation of attention to a spatial location, and 3) Executive control, the resolution of conflict among competing mutually-exclusive responses that enables selective focus. To aid in understanding of attention, the Attention Network Test (ANT) was developed as a brief computerized measure of the efficiency of each of these networks and has been extensively used in a variety of healthy and clinical populations. Several studies have examined differences in ERPs during the ANT in healthy aging and clinical populations such as ADHD, schizophrenia, and traumatic brain injury (TBI) but have not conducted repeated sessions of the task to evaluate changes over time. While the ANT has been shown to be robustly sensitive to a range of cognitive and/or neuropsychological disorders, the reliability of the ANT across multiple sessions, particularly in terms of neural activity measures, has not been previously examined. An important focus of the proposed research regards the stability of neural measures reflecting activity of each of three different attention networks. One method for examining neural activity involves time locked electroencephalographic (EEG) recordings of brain activity or scalp-recorded brain event-related potentials (ERPs). ERPs can provide insights into the neural correlates of cognitive processes elicited by an experimental task as well as the neural time course. Particularly relevant to this study, the visual N1, a negative-going ERP deflection occurring ~150-200 milliseconds (ms) post-stimulus. N1 amplitude is considered to index attentional allocation. Additionally, a later-occurring positive-going deflection occurring ~300-ms post-stimulus, P3, reflects processes associated with stimulus evaluation and categorization. Previous research in our lab has shown that N1 and P3 are differentially sensitive to attention network functioning probed using the ANT in neurologically-healthy controls and are sensitive to attentional impairment in TBI survivors. Thus, the study team will focus on the stability of N1 and P3 waveforms across the 4 sessions. Previous studies have examined reliability and stability of behavioral measures of the ANT by evaluating the reliability of reaction time (RT) and error rates over multiple sessions. Ishigami reported good temporal stability of network scores across 10 sessions, although some practice effects were seen in orienting and executive-control attention networks. Importantly, no prior work has examined the temporal stability of ERPs with repeated ANT performance, which is among the primary aims of the proposed research. Finally, in an exploratory manner, the investigators will extend findings from one of our earlier studies demonstrating altitudinal attentional biases for upper vertical space in healthy participants and the absence of such biases in TBI survivors. Specifically, the investigators will examine which of three attentional networks are sensitive to such biases in healthy controls and determine the ERP signatures of these biases.
- Being tested
- Attention Network Task
- Keywords
- cognitive process, visuospatial attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Network TaskBehavioural
Also called Electroencephalography
The Attention Network Test (ANT) is a computerized cognitive task designed to efficiently probe three independent but interactive attentional networks (alerting, orienting, executive control) in a single task paradigm.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Participants will include 15 healthy men and women aged 18-40 years, right-hand dominant, Native English speakers, with normal or corrected-to-normal vision. Receives: Behavioral: Attention Network Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the temporal stability of behavioral measures of three attention networks: change in reaction time across four sessions
The Attention Network Task (ANT) combines a covert cuing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention. These distinct components of attention are: alerting, orienting, and executive control. These facets of attention will be assessed at 4 time points scheduled 1 week apart as follows: ANT Alerting Reaction Time score, ANT Orienting Reaction Time score and ANT Executive-control Reaction Time score. The lower the score the faster the reaction time.
Measured: Week 1; Week 2; Week 3; Week 4
Change in the temporal stability of neural measures of three attention networks using scalp-recorded electroencephalography (EEG)
Scalp-recorded brain event related potentials (ERP) will be acquired from 64 EEG sensors while participants perform the ANT reflecting alerting, orienting, and executive control components of attention. These facets of attention will be assessed at 4 time points scheduled 1 week apart. ANT alerting will be interrogated by examining the amplitude of the P300 component of the ERP in microvolts, as will orienting and executive-control.
Measured: Week 1; Week 2; Week 3; Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start31 Jan 2019
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stability of Attentional Networks Over Multiple Sessions of Computerized TaskStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Perlstein, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033731
- Sponsor's protocol ID
- IRB201600188
- Other IDs
- 0217BBRC-02
- Status last verified
- Feb 2020
- First submitted
- 19 Jul 2019
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Stability of Behavioral and Neural Measures of Attention Networks Across Multiple Sessions
- ClinicalTrials.gov ID
- NCT04033731
- Acronym / sponsor ID
- IRB201600188
- Keywords
- cognitive process, visuospatial attention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 26 Jul 2019 (actual)
- 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.
The purpose of this research study is to learn more about the stability over multiple recording sessions of brainwave activity during a computerized task that measures different types of attention.
Detailed description
Attention is the backbone of cognitive systems and is requisite for other cognitive processes vital to everyday functioning, such as memory, problem solving, language skills, and the cognitive control of behavior. Impairments in attention can result from a variety of factors, such as brain injury, and neurodegenerative and neurodevelopmental disorders, as well as various psychopathologies. A prominent multi-component model of visuospatial attention developed by Posner and colleagues conceptualizes visuospatial attention as an "organ system" comprised of three independent, yet interactive networks which include: 1) Alerting, the generation and maintenance of a vigilant state that facilitates the processing of an upcoming stimulus, 2) Orienting, the disengagement, shifting, and reallocation of attention to a spatial location, and 3) Executive control, the resolution of conflict among competing mutually-exclusive responses that enables selective focus. To aid in understanding of attention, the Attention Network Test (ANT) was developed as a brief computerized measure of the efficiency of each of these networks and has been extensively used in a variety of healthy and clinical populations. Several studies have examined differences in ERPs during the ANT in healthy aging and clinical populations such as ADHD, schizophrenia, and traumatic brain injury (TBI) but have not conducted repeated sessions of the task to evaluate changes over time. While the ANT has been shown to be robustly sensitive to a range of cognitive and/or neuropsychological disorders, the reliability of the ANT across multiple sessions, particularly in terms of neural activity measures, has not been previously examined. An important focus of the proposed research regards the stability of neural measures reflecting activity of each of three different attention networks. One method for examining neural activity involves time locked electroencephalographic (EEG) recordings of brain activity or scalp-recorded brain event-related potentials (ERPs). ERPs can provide insights into the neural correlates of cognitive processes elicited by an experimental task as well as the neural time course. Particularly relevant to this study, the visual N1, a negative-going ERP deflection occurring ~150-200 milliseconds (ms) post-stimulus. N1 amplitude is considered to index attentional allocation. Additionally, a later-occurring positive-going deflection occurring ~300-ms post-stimulus, P3, reflects processes associated with stimulus evaluation and categorization. Previous research in our lab has shown that N1 and P3 are differentially sensitive to attention network functioning probed using the ANT in neurologically-healthy controls and are sensitive to attentional impairment in TBI survivors. Thus, the study team will focus on the stability of N1 and P3 waveforms across the 4 sessions. Previous studies have examined reliability and stability of behavioral measures of the ANT by evaluating the reliability of reaction time (RT) and error rates over multiple sessions. Ishigami reported good temporal stability of network scores across 10 sessions, although some practice effects were seen in orienting and executive-control attention networks. Importantly, no prior work has examined the temporal stability of ERPs with repeated ANT performance, which is among the primary aims of the proposed research. Finally, in an exploratory manner, the investigators will extend findings from one of our earlier studies demonstrating altitudinal attentional biases for upper vertical space in healthy participants and the absence of such biases in TBI survivors. Specifically, the investigators will examine which of three attentional networks are sensitive to such biases in healthy controls and determine the ERP signatures of these biases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Behavioral: Attention Network TaskParticipants will include 15 healthy men and women aged 18-40 years, right-hand dominant, Native English speakers, with normal or corrected-to-normal vision. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Controls
Key inclusion criteria (3 listed)
- right-hand dominant
- Native English speakers
- with normal or corrected-to-normal vision
Key exclusion criteria (5 listed)
- Not right-hand dominant
- Does not speak english as a native language
- No history of neurological disorder such as stroke, epilepsy or chronic seizure disorder, traumatic brain injury or concussion, psychiatric disorder such as schizophrenia, bipolar disorder, major depression or anxiety disorder, any psychiatric inpatient hospitalization for any of these disorders, or previously diagnosed learning disability
- Currently taking any prescribed medications for anxiety, depression, or seizures
- Alcohol use more than 3 days a week
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 |
|---|---|---|
| Attention Network TaskAlso: ElectroencephalographyThe Attention Network Test (ANT) is a computerized cognitive task designed to efficiently probe three independent but interactive attentional networks (alerting, orienting, executive control) in a single task paradigm. | Behavioural | Controls |
Primary outcome
Change in the temporal stability of behavioral measures of three attention networks: change in reaction time across four sessions
Time frame: Week 1; Week 2; Week 3; Week 4
The Attention Network Task (ANT) combines a covert cuing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention. These distinct components of attention are: alerting, orienting, and executive control. These facets of attention will be assessed at 4 time points scheduled 1 week apart as follows: ANT Alerting Reaction Time score, ANT Orienting Reaction Time score and ANT Executive-control Reaction Time score. The lower the score the faster the reaction time.
Change in the temporal stability of neural measures of three attention networks using scalp-recorded electroencephalography (EEG)
Time frame: Week 1; Week 2; Week 3; Week 4
Scalp-recorded brain event related potentials (ERP) will be acquired from 64 EEG sensors while participants perform the ANT reflecting alerting, orienting, and executive control components of attention. These facets of attention will be assessed at 4 time points scheduled 1 week apart. ANT alerting will be interrogated by examining the amplitude of the P300 component of the ERP in microvolts, as will orienting and executive-control.
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 24 Feb 2020.
- Individual participant dataSharing planned: No
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.
William Perlstein, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stability of Attentional Networks Over Multiple Sessions of Computerized Task, run by University of Florida at 1 site in United States.
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 3 inclusion and 5 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 24 Feb 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 United States. 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?
Change in the temporal stability of behavioral measures of three attention networks: change in reaction time across four sessions (time frame: Week 1; Week 2; Week 3; Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2020.