Recruiting

Observational Study

Sponsor:

University of Southern California

Code:

NCT07110688

Conditions

No Condition

Study Mental State in Healthy Populations and Drug-resistant Epilepsy Patients With Existing iEEG

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Virtual human social interaction

Cold pressor test

Study Details

Brief summary:

In this program, the investigators will develop novel multimodal neural-behavioral-physiological monitoring tools (software and hardware), and machine learning models for mental states within social processes and beyond. The tools consist of a multimodal skin-like wearable sensor for physiological and biochemical sensing; a conversational virtual human platform to evoke naturalistic social processes; audiovisual affect recognition software; synchronization tools; and machine learning methods to model the multimodal data. The investigators will demonstrate the tools in healthy subjects without neural recordings and in patients with drug-resistant epilepsy who already have intracranial EEG (iEEG) electrodes implanted based on clinical criteria for standard monitoring to localize seizures, which is unrelated to our study.

Conditions

No Condition

Study Mental State in Healthy Populations and Drug-resistant Epilepsy Patients With Existing iEEG

Study ID

NCT07110688

Start date

Aug 1, 2024

Status verified date

Jul, 2025

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

For the healthy population, all subjects over the age of 18 who are able and willing to give informed consent will be eligible.

For the epilepsy population, inclusion criteria are:

  • Patients who suffer from drug-resistant epilepsy and already have intracranial EEG (iEEG) electrodes implanted based on clinical criteria for their standard seizure localization (unrelated to our study) will be eligible. Most patients are healthy adults outside of their epilepsy.
  • Subjects >= 18 are only included in this study.
  • All patients with the above conditions and with already-implanted electrodes who are willing to participate and able to cooperate and follow research instructions will be recruited.

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Behavioral tasks to assess mental states

Interventions

Virtual human social interaction

The participants will perform a social interaction with the virtual human agent platform to assess mental states.

Cold pressor test

Healthy participants will immerse one hand in cold water for less than 3 minutes, while physiological data will be collected by the new wearable sensor from the other hand.

Primary outcome measure

  • Positive and Negative Affect Schedule (PANAS) [ Time Frame: 7-10 days ]
  • Visual Analog Scale (VAS) [ Time Frame: 7-10 days ]
  • Hamilton Depression Rating Scales (HAMD-6) [ Time Frame: 7-10 days ]
  • Hamilton Anxiety Rating Scales (HAM-A) [ Time Frame: 7-10 days ]
  • Immediate Mood Scalar (IMS) [ Time Frame: 7-10 days ]
  • Fear of Negative Evaluation Brief [ Time Frame: 7-10 days ]

Central Contacts and Locations

Locations

Rancho Los Amigos National Rehabilitation Center

Recruiting

Downey, California, United States, 90242

Contacts

Charles Liu, MD, PhD

323-226-7421cliu@usc.edu

University of Southern California

Recruiting

Los Angeles, California, United States, 90007

Contacts

Maryam M Shanechi, PhD

213-740-1377shanechi@usc.edu

HyeongChan Jo, PhD

hj_380@usc.edu

Principal Investigator:

Maryam M Shanechi, PhD

More Information

Sponsor

University of Southern California

Last update posted

Oct 1, 2025

Last verified

Jul, 2025

Keywords

  • neurotechnology
  • neuropsychiatric disorders
  • 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 2025-10-01.