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Electrochemical and Electrophysiological Study

Sponsored by University of Arizona

About this trial

Last updated 2 years ago

Study ID

STUDY00000295

Status

Enrolling by invitation

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 3 years ago

What is this trial about?

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. In addition to computerized testing, the investigators plan to characterize subjects' behavior on related cognitive or affective components. Some neuropsychological questionnaires, many of which are administered for clinical reasons (listed below under study population), may also be given to patients and healthy control subjects. All patients undergoing epilepsy surgery (the population from which subjects will be selected) 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 subdural 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. No additional neuropsychological testing will be necessary as part of the study itself.

What are the participation requirements?

Yes

Inclusion Criteria

- 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

No

Exclusion Criteria

- Clinically significant cognitive dysfunction.

- 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.

- Current pregnancy or pregnancy planned during the course of the study.

- Cognitive function less than 2 standard deviations below normal on preoperative neuropsychological testing

Locations

Location

Status