Electrochemical and Electrophysiological Study
NCT05273970 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-12-17
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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