Electrochemical and Electrophysiological Study

NCT05273970 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-17

No results posted yet for this study

Summary

This study will utilize computerized algorithms in combination with real-time intracranial neurophysiological and neurochemical recordings and microstimulation to measure cognitive and affective behavior in humans.

Questionnaires or simple behavioral tasks (game-like tasks on a computer or an iPad) may also be given to additionally characterize subjects on related cognitive or affective components. Importantly, for the purposes of understanding the function of the human brain, neural activity can be recorded and probed (i.e. microstimulation) while subjects are performing the same computerized cognitive and affective tasks. These surgeries allow for the in vivo examination of human neurophysiology and are a rare opportunity for such research.

The questionnaires and assessments proposed will provide insights into disorders (and anxiety, depression) and psychological status that we hope to understand in relation to the neurochemistry measures. They will also provide baseline information that may be used to characterize and group the population to further refine our understanding of the neural responses.

In addition to computerized testing, we plan to characterize subjects' behavior on related cognitive or affective components. Some neuropsychological questionnaires, many of which are administered for clinical reasons, may also be given to patients and healthy control subjects.

All patients undergoing epilepsy surgery or deep brain stimulation undergo a standard clinical neuropsychological battery to assess aspects of cognitive function. This is a regular aspect of their clinical assessment carried out prior to consideration for study inclusion. All participants are selected uniformly because they are undergoing surgery for intracranial electrode implantation. No particular ethnic group or population is targeted by or excluded from the study.

Those to be considered for inclusion in the proposed study performing more than 2 standard deviations below the mean on any aspect of cognitive functioning as determined by standard preoperative neuropsychological testing will be excluded from the study.

Conditions

  • Cognition
  • Medically Intractable Epilepsy

Interventions

OTHER

Behavioral testing under intracranial monitoring

After standard of care surgery to implant the electrodes is complete and patients have have recovered satisfactorily from the procedure, they will be asked to perform some computer based tasks to answer questions about pretend financial decisions, pay attention to certain images, watch videos, look at images, listen to sounds, or move a joystick.

Sponsors & Collaborators

  • Arizona State University

    collaborator OTHER
  • Virginia Polytechnic Institute and State University

    collaborator OTHER
  • University of Arizona

    lead OTHER

Principal Investigators

  • Robert Bina, MD · University of Arizona

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-07
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05273970 on ClinicalTrials.gov