CognitionNCT04652856
Neurocognitive Basis of Attention and Eye Movement Guidance in the Real World Scenes
A study testing Electrical Brain Stimulation in people with Cognition and Attention, run by Avniel Ghuman at 1 site in United States.
Trial summary
The objective of this study is to determine the effects of electrical brain stimulation (EBS) on visual search in natural scenes in humans. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cognition, Attention, Eye Movements
- What is being tested?
- Electrical Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2022to Jun 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have intracranial EEG electrodes implanted for stage II epilepsy planning.
- Have adequate cognitive and communication ability to give informed consent, understand instructions, and follow direction.
- Be able to understand the tasks and provide responses.
- IQ > 75 (done as part of standard-of-care neuropsychological testing as part of the surgical treatment for epilepsy)
- Speak English
Who cannot join
- Inability to understand or perform the tasks outlined in this protocol
- In excessive postoperative discomfort.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine the effects of electrical brain stimulation (EBS) on visual search in natural scenes in humans.
Read the detailed description
The ability to conduct a visual search for an object in a naturalistic scene is a crucial component of everyday interactions with the environment. This process requires the recognition of different items, accessing stored semantic knowledge about those items and their relationships with other objects, and guiding vision based on that knowledge. Classical models of attention emphasize low-level visual salience maps for attentional guidance. However, behavioral studies increasingly support a role for object knowledge in guiding attention and eye movements. Despite strong behavioral evidence that conceptual information about objects and scenes is critical for real world guidance of attention, very little is known about the neural basis of the guidance of attention based on meaning.
Previous human imaging studies have identified several brain regions that represent object and scene/context knowledge as it relates to visual recognition. In particular, regions of the temporal lobes (inferior temporal regions (ITC), parahippocampal cortex (PHC), and the hippocampus) are critical for perceiving and understanding objects, but little is known about the role of these individual regions in how they interact to guide attention and eye movements in real-world scenes.
Electrical brain stimulation is routinely performed clinically in the surgical treatment of epilepsy patients, both intraoperatively and using implanted electrodes. It is used as standard of care both to map eloquent brain function prior to surgical treatment for epilepsy and to map the seizure network. The purpose of this study is to gain a better understanding of the information flow and neural dynamics of the brain, examining the impact of electrical brain stimulation on stimulus search time, accuracy, and eye movement trajectories.
- Conditions
- Cognition, Attention, Eye Movements
- Being tested
- Electrical Brain Stimulation, Sham Electrical Brain Stimulation
- Keywords
- Visual Attention, Naturalistic Vision, Intracranial Electroencephalography, Electrical Brain Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Brain StimulationDevice
Electrical Brain Stimulation (EBS) will be used to disrupt local neural activity in inferior temporal regions (ITC), parahippocampal cortex (PHC), the hippocampus, and control regions. The effects of EBS will be examined on attention and eye movement behavior, and all participants will receive both EBS and sham electrical brain stimulation.
Sham Electrical Brain StimulationDevice
Sham electrical brain stimulation (SEBS) will be applied to inferior temporal regions (ITC), parahippocampal cortex (PHC), the hippocampus, and control regions. The effects of SEBS will be examined on attention and eye movement behavior, and all participants will receive both SEBS and EBS.
| Study group | Role | What they receive |
|---|---|---|
| Electrical and Sham Electrical Brain Stimulation | Experimental | Electrical brain stimulation and sham electrical brain stimulation will be administered to all participants. Receives: Device: Electrical Brain Stimulation; Device: Sham Electrical Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of eye fixations during electrical brain stimulation (EBS) vs. sham electrical brain stimulation (SEBS).
Eye fixations will be assessed using an eye tracking device, which collects videos of eye movements. Participants will be presented with an image of a scene, and asked to locate a target object. The incidence of eye fixations occurring before participants locate the target object will be measured at preferred and control brain regions during EBS and SEBS.
Measured: Eye fixation incidence will be assessed during the intervention, through study completion, up to 1 week on average.
Secondary outcomes (2)
Search time for target object during EBS vs. SEBS.
Visual search time will be assessed by asking participants to answer a simple question about a target object in an image of a scene as quickly and accurately as possible. The question will presented to the participants, followed by the image of the scene. The search time to locate the target object and respond to the question will be measured at preferred and control brain regions during EBS and SEBS.
Measured: Search Time will be assessed during the intervention, through study completion, up to 1 week on average.
Identification accuracy during EBS vs. SEBS.
Identification accuracy rate will be assessed based on the participants' correct responses for identifying a target object in an image of a scene (described in Outcomes 1 and 2). The search time to locate the target object will be measured at preferred and control brain regions during EBS and SEBS.
Measured: Identification accuracy will be assessed during the intervention, through study completion, up to 1 week on average.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study startMay 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: We are withdrawing this study due to issues with recruitment. These issues arose as a result of the COVID-19 pandemic, effecting the availability of patients and our ability as a lab to work with these patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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
- Model description
- All participants will undergo both electrical brain stimulation (EBS) and sham electrical brain stimulation (SEBS) at brain locations where alteration of visual attention behavior is expected to occur, as well as at control locations. The participants will be informed that they will receive both EBS and SEBS, but blinded to the location of each trial and whether the trial is EBS or SEBS. Participants will also be blinded to the objectives of stimulation. The order of stimulation locations and whether the trial is EBS or SEBS will be randomized.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avniel Ghuman
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor-investigator, Avniel Ghuman, University of Pittsburgh
- Investigators
- Avniel S Ghuman, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652856
- Sponsor's protocol ID
- STUDY19090010
- Other IDs
- 1R21EY030297-01A1
- Status last verified
- Jun 2022
- First submitted
- 4 Nov 2020
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Basis of Attention and Eye Movement Guidance in the Real World Scenes
- ClinicalTrials.gov ID
- NCT04652856
- Acronym / sponsor ID
- STUDY19090010
- Conditions
- Cognition, Attention, Eye Movements
- Keywords
- Visual Attention, Naturalistic Vision, Intracranial Electroencephalography, Electrical Brain Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We are withdrawing this study due to issues with recruitment. These issues arose as a result of the COVID-19 pandemic, effecting the availability of patients and our ability as a lab to work with these patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Avniel GhumanUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- May 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 3 Dec 2020 (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 objective of this study is to determine the effects of electrical brain stimulation (EBS) on visual search in natural scenes in humans.
Detailed description
The ability to conduct a visual search for an object in a naturalistic scene is a crucial component of everyday interactions with the environment. This process requires the recognition of different items, accessing stored semantic knowledge about those items and their relationships with other objects, and guiding vision based on that knowledge. Classical models of attention emphasize low-level visual salience maps for attentional guidance. However, behavioral studies increasingly support a role for object knowledge in guiding attention and eye movements. Despite strong behavioral evidence that conceptual information about objects and scenes is critical for real world guidance of attention, very little is known about the neural basis of the guidance of attention based on meaning.
Previous human imaging studies have identified several brain regions that represent object and scene/context knowledge as it relates to visual recognition. In particular, regions of the temporal lobes (inferior temporal regions (ITC), parahippocampal cortex (PHC), and the hippocampus) are critical for perceiving and understanding objects, but little is known about the role of these individual regions in how they interact to guide attention and eye movements in real-world scenes.
Electrical brain stimulation is routinely performed clinically in the surgical treatment of epilepsy patients, both intraoperatively and using implanted electrodes. It is used as standard of care both to map eloquent brain function prior to surgical treatment for epilepsy and to map the seizure network. The purpose of this study is to gain a better understanding of the information flow and neural dynamics of the brain, examining the impact of electrical brain stimulation on stimulus search time, accuracy, and eye movement trajectories.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo both electrical brain stimulation (EBS) and sham electrical brain stimulation (SEBS) at brain locations where alteration of visual attention behavior is expected to occur, as well as at control locations. The participants will be informed that they will receive both EBS and SEBS, but blinded to the location of each trial and whether the trial is EBS or SEBS. Participants will also be blinded to the objectives of stimulation. The order of stimulation locations and whether the trial is EBS or SEBS will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Electrical and Sham Electrical Brain Stimulation | Experimental | Device: Electrical Brain Stimulation, Device: Sham Electrical Brain StimulationElectrical brain stimulation and sham electrical brain stimulation will be administered to all participants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have intracranial EEG electrodes implanted for stage II epilepsy planning.
- Have adequate cognitive and communication ability to give informed consent, understand instructions, and follow direction.
- Be able to understand the tasks and provide responses.
- IQ > 75 (done as part of standard-of-care neuropsychological testing as part of the surgical treatment for epilepsy)
- Speak English
Key exclusion criteria (2 listed)
- Inability to understand or perform the tasks outlined in this protocol
- In excessive postoperative discomfort.
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 |
|---|---|---|
| Electrical Brain StimulationElectrical Brain Stimulation (EBS) will be used to disrupt local neural activity in inferior temporal regions (ITC), parahippocampal cortex (PHC), the hippocampus, and control regions. The effects of EBS will be examined on attention and eye movement behavior, and all participants will receive both EBS and sham electrical brain stimulation. | Device | Electrical and Sham Electrical Brain Stimulation |
| Sham Electrical Brain StimulationSham electrical brain stimulation (SEBS) will be applied to inferior temporal regions (ITC), parahippocampal cortex (PHC), the hippocampus, and control regions. The effects of SEBS will be examined on attention and eye movement behavior, and all participants will receive both SEBS and EBS. | Device | Electrical and Sham Electrical Brain Stimulation |
Primary outcome
Incidence of eye fixations during electrical brain stimulation (EBS) vs. sham electrical brain stimulation (SEBS).
Time frame: Eye fixation incidence will be assessed during the intervention, through study completion, up to 1 week on average.
Eye fixations will be assessed using an eye tracking device, which collects videos of eye movements. Participants will be presented with an image of a scene, and asked to locate a target object. The incidence of eye fixations occurring before participants locate the target object will be measured at preferred and control brain regions during EBS and SEBS.
2 secondary outcomes
Search time for target object during EBS vs. SEBS.
Time frame: Search Time will be assessed during the intervention, through study completion, up to 1 week on average.
Identification accuracy during EBS vs. SEBS.
Time frame: Identification accuracy will be assessed during the intervention, through study completion, up to 1 week on average.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Avniel S Ghuman, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Brain Stimulation in people with Cognition and Attention, run by Avniel Ghuman 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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 13 Jun 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of eye fixations during electrical brain stimulation (EBS) vs. sham electrical brain stimulation (SEBS). (time frame: Eye fixation incidence will be assessed during the intervention, through study completion, up to 1 week on average.). 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 13 Jun 2022.