Using Direct Brain Stimulation to Study Cognitive Electrophysiology

  • STATUS
    Recruiting
  • participants needed
    250
  • sponsor
    University of Pennsylvania
Updated on 19 February 2024
brain stimulation
epilepsy
electrical stimulation

Summary

This project forms a multi-site research collaboration to carry out verbal and spatial memory experiments in patient volunteers to better understand the neural bases of human memory, employing direct electrical brain stimulation as a tool to study those dynamics and their relationship to memory performance.

Description

The study protocol outlines fundamental experiments to understand the neural dynamics underlying human memory and use direct brain stimulation as a tool (intervention) to study the relationship between those dynamics and memory performance. The investigators will collect recording and stimulation data from 250 patient volunteers as they perform carefully-matched verbal and spatial memory tasks. During non-stimulation sessions, the investigators will measure correlative neural biomarkers of memory encoding and retrieval using standard clinical depth electrodes and micro-wire recordings. To test the causal role of these biomarkers, the investigators will employ direct brain stimulation to briefly modulate neural activity, and measure ensuing changes in behavioral performance. With a set of causal biomarkers and predictive models in hand, the investigators will finally ask whether model-driven stimulation paradigms offer the investigators the ability to reliably modulate neural activity, and consequent behavior, in real-time.

Details
Condition Epilepsy Intractable
Age 18-65 years
Treatment Direct electrical stimulation
Clinical Study IdentifierNCT04286776
SponsorUniversity of Pennsylvania
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects will be enrolled who are expected to undergo intracranial
electroencephalographic monitoring as part of a standard clinical procedure
for the treatment of pharmacologically resistant epilepsy

Exclusion Criteria

The following individuals will be excluded
Any cognitive impairments that would limit their ability to participate in the memory testing
Any physical disability that would limit their ability to perform cognitive tasks within normal limits
Any psychiatric condition that would limit their ability to provide informed consent or to perform cognitive tasks within normal limits
Any medical condition that would, in the investigator's opinion, limit the subject's participation in the study
Who are pregnant
Unable or unwilling to provide informed consent
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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