Model-based Electrical Brain Stimulation
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of Southern California
- Study ID
- NCT05327387
- Status
- Recruiting
Conditions
- Medication Refractory Epilepsy Patients With Electrodes Already Implanted Based on Clinical Criteria for Standard Monitoring
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- model-based electrical brain stimulation — OTHERElectrical pulse train stimulation delivered to medication refractory epilepsy patients with electrodes already implanted based on clinical criteria for standard monitoring unrelated to this study. The delivery of the electrical brain stimulation can be guided by neural biomarkers of symptom levels computed from ongoing neural activity and by input-output models of neural response to stimulation therapy. The parameters of electrical stimulation will be constrained to be within clinically safe ranges.
Study Details
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 medications or psychotherapy, which makes it critical to find an alternative therapy. Applying electrical stimulation at various brain targets has shown promise but there is a critical need to improve efficacy. Given inter- and intra-subject variabilities in neuropsychiatric disorders, this study aims to enable personalizing the stimulation therapy via i) tracking a patient's own symptoms based on their neural activity, and ii) a model of how their neural activity responds to stimulation therapy. The study will develop the modeling elements needed to realize a model-based personalized system for electrical brain stimulation to achieve this aim. The study will provide proof-of-concept demonstration in epilepsy patients who already have intracranial electroencephalography (iEEG) electrodes implanted for their standard clinical monitoring unrelated to this study, and who consent to being part of the study.
Key Dates
- Start date
- Feb 8, 2022
- Status verified
- Jun 2025
- Primary completion
- Mar 31, 2026
- Completion
- Mar 31, 2026
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: model-based electrical brain stimulation
Primary Outcome Measure
Decoded depression symptom ratings based on neural activity [ Time Frame: 5-10 days ]
Central Contacts
- Maryam M Shanechi, PhD213-740-1377
- HyeongChan Jo, PhD
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | Maryam M Shanechi, PhD (PRINCIPAL_INVESTIGATOR) |
| University of California, San Francisco | San Francisco | California | 94143 | Edward F Chang, MD (PRINCIPAL_INVESTIGATOR) |