Status:
RECRUITING
Model-based Electrical Brain Stimulation
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
University of California, San Francisco
National Institute of Mental Health (NIMH)
Conditions:
Medication Refractory Epilepsy Patients With Electrodes Already Implanted Based on Clinical Criteria for Standard Monitoring
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Neuropsychiatric disorders are a leading cause of disability worldwide with depressive disorders being one of the most disabling among them. Also, millions of patients do not respond to current medica...
Detailed Description
The investigators will conduct the study for each subject during their stay in the epilepsy monitoring unit (EMU), which is dictated purely based on their standard clinical needs unrelated to this stu...
Eligibility Criteria
Inclusion
- Patients being evaluated for surgical treatment of medication refractory epilepsy and brain tumors will be studied. ONLY patients with electrodes implanted based on clinical criteria to locate their seizure focus will be studied. Most patients are healthy adults, outside of their epilepsy and/or brain tumor.
- Subjects \>= 18 are only included in this study.
- All patients with the above conditions and with implanted electrode arrays who are willing to participate and able to cooperate and follow research instructions will be recruited. However, analysis of research recording data will focus on those subjects with an IQ \>= 80, with no impairments of reading, naming, or articulation (to minimize confounds such as abnormal language processing that may affect their self-reporting with the questionnaire), and with no cerebral pathology affecting the cortical regions from which recordings are made.
Exclusion
- Subjects \< 18 years old will be excluded from this study due to the high concordance of developmental disorders (cognitive and language-related) in pediatric epilepsies.
- There will be no involvement of special classes of subjects, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
- Patients who are unable to give informed consent due to a brain disorder will be excluded from the study, as it is very likely that they would be unable to carry out the tasks demanded by the study.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05327387
Start Date
February 8 2022
End Date
March 31 2026
Last Update
September 22 2025
Active Locations (2)
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1
University of Southern California
Los Angeles, California, United States, 90089
2
University of California, San Francisco
San Francisco, California, United States, 94143