Status:
ENROLLING_BY_INVITATION
Electrochemical and Electrophysiological Study
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Arizona State University
Virginia Polytechnic Institute and State University
Conditions:
Cognition
Medically Intractable Epilepsy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study will utilize computerized algorithms in combination with real-time intracranial neurophysiological and neurochemical recordings and microstimulation to measure cognitive and affective behav...
Detailed Description
Dysfunction in neurotransmission and neurophysiology can result in a range of psychiatric conditions including depression, anxiety, chronic pain, addiction disorders, and problems with attention (atte...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05273970
Start Date
September 7 2022
End Date
February 1 2027
Last Update
December 17 2025
Active Locations (1)
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1
Banner - University Medical Center, Phoenix campus
Phoenix, Arizona, United States, 85006