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Neurocognitive Basis of Attention and Eye Movement Guidance in the Real World Scenes

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ClinicalTrials.gov Identifier: NCT04652856
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : January 8, 2021
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Avniel Ghuman, University of Pittsburgh

Brief Summary:
The objective of this study is to determine the effects of electrical brain stimulation (EBS) on visual search in natural scenes in humans.

Condition or disease Intervention/treatment Phase
Cognition Attention Eye Movements Device: Electrical Brain Stimulation Device: Sham Electrical Brain Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: Neurocognitive Basis of Attention and Eye Movement Guidance in the Real World Scenes
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Electrical and Sham Electrical Brain Stimulation
Electrical brain stimulation and sham electrical brain stimulation will be administered to all participants.
Device: Electrical Brain Stimulation
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.

Device: Sham Electrical Brain Stimulation
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Inability to understand or perform the tasks outlined in this protocol
  • In excessive postoperative discomfort.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652856


Contacts
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Contact: Avniel S Ghuman, PhD (412) 648-0077 ghumana@upmc.edu
Contact: Michael J Ward, MS (412) 648-0073 mjw108@pitt.edu

Locations
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United States, Pennsylvania
UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Michael J Ward, MS    412-648-0073    mjw108@pitt.edu   
Sponsors and Collaborators
Avniel Ghuman
National Eye Institute (NEI)
Investigators
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Principal Investigator: Avniel S Ghuman, PhD University of Pittsburgh
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Responsible Party: Avniel Ghuman, Associate Professor, Neurological Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04652856    
Other Study ID Numbers: STUDY19090010
1R21EY030297-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Avniel Ghuman, University of Pittsburgh:
Visual Attention
Naturalistic Vision
Intracranial Electroencephalography
Electrical Brain Stimulation