Recruiting

Electrical Brain Stimulation

Sponsor:

University of Southern California

Code:

NCT05327387

Conditions

Medication Refractory Epilepsy Patients With Electrodes Already Implanted Based on Clinical Criteria for Standard Monitoring

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

model-based electrical brain stimulation

Study Details

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 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.

Conditions

Medication Refractory Epilepsy Patients With Electrodes Already Implanted Based on Clinical Criteria for Standard Monitoring

Study ID

NCT05327387

Start date

Feb 8, 2022

Status verified date

Jun, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: model-based electrical brain stimulation

Interventions

model-based electrical brain stimulation

Electrical 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.

Primary outcome measure

  • Decoded depression symptom ratings based on neural activity [ Time Frame: 5-10 days ]

Central Contacts and Locations

Central contacts

Maryam M Shanechi, PhD

213-740-1377shanechi@usc.edu

HyeongChan Jo, PhD

hj_380@usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

Maryam Shanechi, PhD

213-740-1377shanechi@usc.edu

Principal Investigator:

Maryam M Shanechi, PhD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Edward F Chang, MD

415-502-7346edward.chang@ucsf.edu

Principal Investigator:

Edward F Chang, MD

More Information

Sponsor

University of Southern California

Last update posted

Sep 22, 2025

Last verified

Jun, 2025

Keywords

  • deep brain stimulation
  • model-based stimulation
  • neural biomarkers of depression
  • neurotechnology
  • neuropsychiatric disorders
  • depression
  • brain-machine interface

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2025-09-22.