Novel Multimodal Neural, Physiological, and Behavioral Sensing and Machine Learning for Mental States

Not Applicable

Recruiting

• Conditions: No Condition; Study Mental State in Healthy Populations and Drug-resistant Epilepsy Patients With Existing iEEG

• Registration Number: NCT07110688
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-18
• Study First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Positive and Negative Affect Schedule (PANAS)	7-10 days	Momentary self-reports of the Positive and Negative Affect Schedule (PANAS) will be administered in a tablet-based application, which measures momentary positive and negative affect. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.
Visual Analog Scale (VAS)	7-10 days	Momentary self-reports of the Visual Analog Scale (VAS) of depression, anxiety, and energy will be administered in a tablet-based application. These are fast self-reports to indicate the affect level along a line from none to prominent. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.
Hamilton Depression Rating Scales (HAMD-6)	7-10 days	Momentary self-reports of Hamilton Depression Rating Scales (HAMD-6) will be administered in a tablet-based application, which is widely used to measure the severity of the depressive state. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.
Hamilton Anxiety Rating Scales (HAM-A)	7-10 days	Momentary self-reports of Hamilton Anxiety Rating scales (HAM-A) will be administered in a tablet-based application, which is widely used to measure the severity of the anxiety state. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.
Immediate Mood Scalar (IMS)	7-10 days	Momentary self-reports of the Immediate Mood Scalar (IMS) will be administered in a tablet-based application, which measures depression and anxiety severity. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.
Fear of Negative Evaluation Brief	7-10 days	Momentary self-reports of Fear of Negative Evaluation Brief will be administered in a tablet-based application. These self-reports return scores indicative of momentary mental state. Self-reports are obtained intermittently from the participants.

Secondary Outcome Measures

Name	Time	Method
Physiological measurements - heart rate variability (HRV)	7-10 days	Heart rate variability will be collected from each participant by using either commercial systems or the new wearable sensor.
Physiological measurements - skin conductance (SC)	7-10 days	Skin conductance will be collected from each participant by using either commercial systems or the new wearable sensor.
Physiological measurements - cortisol level	7-10 days	Cortisol level will be collected from each participant by using either commercial systems or the new wearable sensor.
Neural measurements	7-10 days	In epilepsy patients who already have intracranial EEG recordings for their standard clinical monitoring (unrelated to this study), we will also obtain iEEG activity measurements. EEG power will be the main focus of the analysis, but the raw signal will also be analyzed.

Trial Locations

Locations (2)

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States