- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07617506
Neural Basis of Human Working Memory
This ClinicalTrials.gov entry corresponds to the Neural Basis of Human Working Memory protocol approved under Vanderbilt University Medical Center IRB #251231.
This study investigates the neural activity underlying human working memory, via local field potential changes (macro level) and/or single neuronal spiking changes (micro level) from depth electrodes placed for invasive seizure monitoring. Subjects will complete neurocognitive tasks while neural recordings are collected. Some patients will complete neurocognitive tasks while stimulation is applied via depth electrodes. Further understanding the neural activity changes underlying normal and impaired working memory may help to identify novel diagnostic methods and treatments for impaired working memory and may support the use of stimulation for treatment of memory disorders.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christos Constantinidis, PhD
- Phone Number: +1 (615) 936-2020
- Email: christos.constantinidis.1@Vanderbilt.Edu
Study Contact Backup
- Name: Lucas Chang, BS
- Phone Number: 615-421-3046
- Email: lucas.m.chang@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University Medical Center
-
Contact:
- Christos Constantinidis, PhD
- Phone Number: (615) 936 - 2020
- Email: christos.constantinidis.1@Vanderbilt.Edu
-
Contact:
- Lucas Chang, BA
- Phone Number: 615-421-3046
- Email: lucas.m.chang@vumc.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- Undergoing SEEG monitoring at Vanderbilt University Medical Center
- Age >18
- English speaking
Exclusion Criteria:
- Age <18
- Not able to complete questionnaires (unable to comprehend instructions or follow directions)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Epilepsy patients
All participants will be patients with medically refractory epilepsy who have undergone depth electrode placement for stereo EEG monitoring for seizure localization.
Participants will complete working memory tasks and EEG recordings will be concurrently collected from their depth electrodes.
Some subjects will undergo macro-micro electrode implantation as a part of their SEEG implantation procedure for the purpose of EEG macro (local activity) and micro (single-unit) recordings.
Some subjects will complete working memory tasks with stimulation applied during task completion.
|
Participants complete computerized neurocognitive tasks assessing working memory, response inhibition, decision-making, reward processing, and other related cognitive functions during sEEG monitoring.
Tasks may include the stop signal reaction time task, the n-back working memory task, the delayed response task, the match/nonmatch task, the gambling task, the card guessing task, and the emotional stop signal reaction time task.
Intracranial neural activity is recorded during task performance, and select tasks may include research electrical stimulation delivered through the implanted sEEG electrodes.
Neurophysiology system designed to allow recording of neural signals as well as delivery of neural stimulation.
The system is a portable unit which is connected to cables connected to the clinical electrodes.
Neurophysiology signals from the electrodes can be recorded, amplified, and processed by the unit.
The unit also has the ability to deliver electrical stimulation through the electrodes according to programmed parameters.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Local field potential changes in response to working memory tasks
Time Frame: During patient's epilepsy monitoring stay, approximately 20-30 minutes
|
Local field potential changes are from intracranial neural recordings taken while patients complete spatial working memory tasks.
In the manual remember 1 remember 2 task, patients are instructed to hold down a cursor on a central location box colored one color or another on screen, while two boxes in locations sequentially flash on screen.
Depending on the central location box color, the patient will drag their cursor to the first or second location box shown, after the central box has disappeared from screen.
In the retro remember 1 remember 2 task, the color of the central box color is not shown until both location boxes have flashed onscreen.
In the manual version, the central location box color is constant throughout the trial.
|
During patient's epilepsy monitoring stay, approximately 20-30 minutes
|
|
Single unit neuronal spiking changes in response to memory tasks
Time Frame: During patient's epilepsy monitoring stay, approximately 20-30 minutes
|
Single neuron spiking activity is recorded through SEEG micro neural recordings while patients complete working memory tasks.
|
During patient's epilepsy monitoring stay, approximately 20-30 minutes
|
|
Behavioral performance changes with stimulation
Time Frame: During patient's epilepsy monitoring stay, approximately 20-30 minutes
|
Bipolar stimulation through pre-selected SEEG electrodes in the prefrontal cortex and surrounding areas will occur during the remember 1 remember 2 working memory tasks.
Stimulation will be performed via the Ripple Neuromed Summit system.
Stimulation will be tested with each patient prior to task to determine safety and tolerability, while patient is monitored by a neurosurgeon or neurologist.
|
During patient's epilepsy monitoring stay, approximately 20-30 minutes
|
Collaborators and Investigators
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 251231 (Vanderbilt University Medical Center IRB)
- 1R21MH139624-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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