Electrochemical and Electrophysiological Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
University of Arizona
Study ID
NCT05273970
Status
Enrolling By Invitation

Conditions

  • Cognition
  • Medically Intractable Epilepsy

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioral testing under intracranial monitoring — OTHER
    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.

Study Details

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.

Key Dates

Start date
Sep 7, 2022
Status verified
Dec 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Behavioral testing under intracranial monitoring
    Patients will undergo behavioral tasks while being monitored by intercranial electrodes

Primary Outcome Measure

Neurotransmitter Concentration Fluctuation in Visual Memory [ Time Frame: During Hospitalization - 1-2 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Banner - University Medical Center, Phoenix campusPhoenixArizona85006-

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Banner - University Medical Center, Phoenix campus· Phoenix, AZ

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