- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945628
Basic Experimental Study of Hippocampal Memory Functions
Human Hippocampal Contributions to Rapid Encoding-retrieval Interactions During Memory Formation
Study Overview
Status
Detailed Description
This is a basic experimental study performed with human subjects (BESH) that seeks to understand the mechanisms by which the human hippocampus supports visual sampling during episodic memory formation. Research subjects will be assigned to one of six study experiment conditions that each uses different experimental procedures to test a different portion of the mechanistic hypotheses that are the focus of the study. All of the study conditions involve memory experiments performed during eye-movement tracking, with different methods used to assess brain activity during standardized laboratory conditions in relation to the experimental task. Subjects will perform the experiments while their brain activity is recorded via intracranial EEG (iEEG), which is being performed for clinical purposes as part of epilepsy treatment unrelated to the experimental objectives.
Study Experiment Condition 1: Subjects with iEEG electrodes implanted will perform an eye-tracking memory task in which they view pictures of naturalistic scenes and later undergo memory testing for these scene pictures. For the memory test, studied scenes will be repeated and presented along with novel (foil) scenes. Subjects will attempt to discriminate studied from novel scenes using button press responses. Eye movements will be remotely (noninvasively) tracked using a camera during both study and test. This memory task will take about 1.5 hours to complete. 20 subjects undergoing iEEG recordings as part of epilepsy treatment will be assigned to this study experiment condition.
Study Experiment Condition 2: Subjects with iEEG electrodes implanted will perform an eye-tracking memory task in which they view arrays of everyday objects arranged as a grid and later undergo memory testing for these object image arrays. Half of the object-image arrays are studied actively (subjects view objects in any order they wish) and half are studied passively (viewing patterns are predetermined and subjects must follow along). For the memory test, subjects attempt to pick studied objects from among novel (foil) objects and replace them at studied locations using the computer mouse. Eye movements will be remotely (noninvasively) tracked using a camera during the study phases. This memory task will take about 1.5 hours to complete. 20 subjects undergoing iEEG recordings as part of epilepsy treatment will be assigned to this study experiment condition.
Study Experiment Condition 3: The same 20 subjects with iEEG electrodes implanted who perform Study Experiment Condition 2 will perform the same eye-tracking memory task described for Study Experiment Condition 1. For these subjects, high-frequency electrical stimulation will be delivered through the iEEG electrodes on a subset of study trials, with half of stimulated trials receiving stimulation of the hippocampus and the other half receiving stimulation of the amygdala. This memory task will take about 1.5 hours to complete and will be performed on a different day of their inpatient visit than the procedures for Study Experiment Condition 2.
Study Experiment Condition 4: The same 20 subjects with iEEG electrodes implanted who perform Study Experiment Condition 1 will perform the same eye-tracking memory task described for Study Experiment Condition 2. For these subjects, high-frequency electrical stimulation will be delivered through the iEEG electrodes on a subset of study trials, with half of stimulated trials receiving stimulation of the hippocampus and the other half receiving stimulation of the amygdala. This memory task will take about 1.5 hours to complete and will be performed on a different day of their inpatient visit than the procedures for Study Experiment Condition 1.
Study Experiment Condition 5: Subjects with iEEG electrodes implanted will perform the same eye-tracking memory task as described for Study Experiment Condition 1. This is a different group of iEEG subjects selected based on having iEEG electrodes implanted in the hippocampus as well as in at least one location of the Dorsal Attention Network (DAN), which is a region of interest for the experiment condition. 20 subjects undergoing iEEG recordings as part of epilepsy treatment will be assigned to this study experiment condition.
Study Experiment Condition 6: The same group of 20 iEEG subjects that are included in Study Experiment Condition 5 will perform the same eye-tracking memory task as described for Study Experiment Condition 2. This experiment condition will be performed on a different day of the inpatient visit than participation in Study Experiment Condition 5.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert Baudo, PhD
- Phone Number: 773-702-9325
- Email: rbaudo@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Medical Center
-
Contact:
- Robert Baudo, PhD
- Phone Number: 773-702-9325
- Email: rbaudo@bsd.uchicago.edu
-
Principal Investigator:
- Joel Voss, PhD
-
Sub-Investigator:
- James Kragel, PhD
-
Sub-Investigator:
- Wilma Bainbridge, PhD
-
Sub-Investigator:
- Peter Warnke, MD
-
Sub-Investigator:
- Nauom Issa, MD, PhD
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern Memorial Hospital
-
Contact:
- Irena Bellinski
- Phone Number: 312-926-1672
- Email: irena.bellinski@nm.org
-
Principal Investigator:
- Stephan Schuele, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18+ years old
- Native English speakers.
- Normal or corrected-to-normal near and far vision.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experiment 1
Subjects with iEEG electrodes implanted will perform an eye-tracking memory task in which they view pictures of naturalistic scenes and later undergo memory testing for these scene pictures.
For the memory test, studied scenes will be repeated and presented along with novel (foil) scenes.
Subjects will attempt to discriminate studied from novel scenes using button press responses.
Eye movements will be remotely (noninvasively) tracked using a camera during both study and test.
This memory task will take about 1.5 hours to complete.
20 subjects undergoing iEEG recordings as part of epilepsy treatment will be assigned to this study experiment condition.
|
Study conditions will involve attempting to memorize visual scenes, attempting to memorize arrays of visual objects, viewing in a self-directed manner, viewing in a passive other-directed manner, and making memory judgments about whether stimuli are studied versus novel.
|
Experimental: Experiment 2
Subjects with iEEG electrodes implanted will perform an eye-tracking memory task in which they view arrays of everyday objects arranged as a grid and later undergo memory testing for these object image arrays.
Half of the object-image arrays are studied actively (subjects view objects in any order they wish) and half are studied passively (viewing patterns are predetermined and subjects must follow along).
For the memory test, subjects attempt to pick studied objects from among novel (foil) objects and replace them at studied locations using the computer mouse.
Eye movements will be remotely (noninvasively) tracked using a camera during the study phases.
This memory task will take about 1.5 hours to complete.
20 subjects undergoing iEEG recordings as part of epilepsy treatment will be assigned to this study experiment condition.
|
Study conditions will involve attempting to memorize visual scenes, attempting to memorize arrays of visual objects, viewing in a self-directed manner, viewing in a passive other-directed manner, and making memory judgments about whether stimuli are studied versus novel.
|
Experimental: Experiment 3
The same 20 subjects with iEEG electrodes implanted who perform Study Experiment Condition 2 will perform the same eye-tracking memory task described for Study Experiment Condition 1.
For these subjects, high-frequency electrical stimulation will be delivered through the iEEG electrodes on a subset of study trials, with half of stimulated trials receiving stimulation of the hippocampus and the other half receiving stimulation of the amygdala.
This memory task will take about 1.5 hours to complete and will be performed on a different day of their inpatient visit than the procedures for Study Experiment Condition 2.
|
Study conditions will involve attempting to memorize visual scenes, attempting to memorize arrays of visual objects, viewing in a self-directed manner, viewing in a passive other-directed manner, and making memory judgments about whether stimuli are studied versus novel.
Study conditions will involve different parameters for electrical stimulation delivered through iEEG electrodes, including the presence of stimulation (no stimulation versus stimulation) and the location of stimulation (hippocampus versus amygdala).
|
Experimental: Experiment 4
The same 20 subjects with iEEG electrodes implanted who perform Study Experiment Condition 1 will perform the same eye-tracking memory task described for Study Experiment Condition 2. For these subjects, high-frequency electrical stimulation will be delivered through the iEEG electrodes on a subset of study trials, with half of stimulated trials receiving stimulation of the hippocampus and the other half receiving stimulation of the amygdala.
This memory task will take about 1.5 hours to complete and will be performed on a different day of their inpatient visit than the procedures for Study Experiment Condition 1.
|
Study conditions will involve attempting to memorize visual scenes, attempting to memorize arrays of visual objects, viewing in a self-directed manner, viewing in a passive other-directed manner, and making memory judgments about whether stimuli are studied versus novel.
Study conditions will involve different parameters for electrical stimulation delivered through iEEG electrodes, including the presence of stimulation (no stimulation versus stimulation) and the location of stimulation (hippocampus versus amygdala).
|
Experimental: Experiment 5
Subjects with iEEG electrodes implanted will perform the same eye-tracking memory task as described for Study Experiment Condition 1.
This is a different group of iEEG subjects selected based on having iEEG electrodes implanted in the hippocampus as well as in at least one location of the Dorsal Attention Network (DAN), which is a region of interest for the experiment condition.
20 subjects undergoing iEEG recordings as part of epilepsy treatment will be assigned to this study experiment condition.
|
Study conditions will involve attempting to memorize visual scenes, attempting to memorize arrays of visual objects, viewing in a self-directed manner, viewing in a passive other-directed manner, and making memory judgments about whether stimuli are studied versus novel.
|
Experimental: Experiment 6
The same group of 20 iEEG subjects that are included in Study Experiment Condition 5 will perform the same eye-tracking memory task as described for Study Experiment Condition 2. This experiment condition will be performed on a different day of the inpatient visit than participation in Study Experiment Condition 5.
|
Study conditions will involve attempting to memorize visual scenes, attempting to memorize arrays of visual objects, viewing in a self-directed manner, viewing in a passive other-directed manner, and making memory judgments about whether stimuli are studied versus novel.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
iEEG theta band power
Time Frame: Outcome assessed 5 minutes after intervention
|
iEEG is used to measure slow and fast theta power
|
Outcome assessed 5 minutes after intervention
|
iEEG phase synchrony to eye movement
Time Frame: Outcome assessed 5 minutes after intervention
|
iEEG is used to measure phase synchronization of theta to eye movements
|
Outcome assessed 5 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eye movements
Time Frame: Outcome assessed 5 minutes after intervention
|
Eye movements are recorded during task performance using a remote camera and analyzed based on the location of gaze and the pattern of gaze among screen location regions of interest
|
Outcome assessed 5 minutes after intervention
|
Memory task performance
Time Frame: Outcome assessed 5 minutes after intervention
|
Subjects attempt to discriminate studied from novel (foil) scenes and object images and to recall the spatial locations of objects.
Outcome measure is recall performance
|
Outcome assessed 5 minutes after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joel Voss, PhD, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB22-1300
- 1R01MH128552 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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