NCT05273970Enrolling by invitation
Electrochemical and Electrophysiological Study
Electrochemical and Electrophysiological Correlates of Human Cognition, Emotion, and Behavior
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 28 Feb 2022
- Start date
- 7 Sept 2022
- Primary completion date
- Feb 2027
- Lead sponsor
- University of Arizona
- Diseases
- Epilepsy
- NCT number
- NCT05273970
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 7 Sept 2022 to the primary completion date, Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Terminal illness associated with \<12 month survival.
- Contraindication to MRI imaging, e.g., morbid obesity, metallic devices such as cardiac pacemakers, some aneurysm clips, or shrapnel.
Other
- Clinically significant cognitive dysfunction.
- Current pregnancy or pregnancy planned during the course of the study.
- Cognitive function less than 2 standard deviations below normal on preoperative neuropsychological testing
Who the study is looking for
- Age 18 to 80 years, inclusive.
- Patients who are candidates for electrode implantation due to pharmacologically intractable epilepsy, or other neurological/psychological disorders for which subdural electrode implantation may be clinically required for treatment.
- Patients competent to give informed consent/assent for the research protocol and parents of children under 18 who are competent to give informed consent on behalf of the child.
- Fluency in English (necessary for uniform cognitive testing).
- Committee approved candidates for brain surgery.
- Medications must be at stable doses for at least 1 month before surgery
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Banner - University Medical Center, Phoenix campus Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.