Personalized electrical brain stimulation for epilepsy patients
Model-based Electrical Brain Stimulation
This study is testing a personalized brain stimulation method for epilepsy patients who don’t respond to medication, to see if it can better help manage their seizures and improve their mood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT05327387 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a personalized approach to electrical brain stimulation for patients with medication refractory epilepsy who already have electrodes implanted for clinical monitoring. By tracking patients' neural activity and their reported symptoms of depression, the researchers will create models that predict how the brain responds to stimulation. The goal is to establish a closed-loop system that tailors stimulation therapy to individual patients, enhancing its efficacy. The study will take place in an epilepsy monitoring unit, where data will be collected from patients during their standard clinical care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with medication refractory epilepsy who have already undergone electrode implantation for clinical monitoring.
Not a fit: Patients under 18 years old or those with significant cognitive impairments affecting their ability to self-report may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatments for patients with epilepsy and potentially other neuropsychiatric disorders.
How similar studies have performed: While the concept of personalized brain stimulation is emerging, this specific model-based approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Los Angeles, California and 1 other locations
- University of Southern California — Los Angeles, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Maryam M Shanechi, PhD — University of Southern California
- Study coordinator: Maryam M Shanechi, PhD
- Email: shanechi@usc.edu
- Phone: 213-740-1377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.