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

NCT04652856 | Withdrawn FDA Device

• 2 other identifiers: STUDY190900101R21EY030297-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition; Attention; Eye Movements

Keywords

Visual Attention; Naturalistic Vision; Intracranial Electroencephalography; Electrical Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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 will be assessed during the intervention, through study completion, up to 1 week on average.

Study Arms (1)

Electrical and Sham Electrical Brain Stimulation

EXPERIMENTAL

Electrical brain stimulation and sham electrical brain stimulation will be administered to all participants.

Device: Electrical Brain Stimulation; Device: Sham Electrical Brain Stimulation

Interventions

Electrical Brain Stimulation DEVICE

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.

Electrical and Sham Electrical Brain Stimulation

Sham Electrical Brain Stimulation DEVICE

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.

Electrical and Sham Electrical Brain Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Avniel Ghuman: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Deep Brain Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Avniel S Ghuman, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Neurological Surgery

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: December 3, 2020
• Study Start: May 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)