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

NCT07110688 | Recruiting

• 1 other identifier: R61MH135407
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Keywords

neurotechnology; neuropsychiatric disorders; brain-machine interface

Outcome Measures

Primary Outcomes (6)

• Positive and Negative Affect Schedule (PANAS)

  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.

  7-10 days

• Visual Analog Scale (VAS)

  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.

  7-10 days

• Hamilton Depression Rating Scales (HAMD-6)

  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.

  7-10 days

• Hamilton Anxiety Rating Scales (HAM-A)

  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.

  7-10 days

• Immediate Mood Scalar (IMS)

  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.

  7-10 days

• Fear of Negative Evaluation Brief

  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.

  7-10 days

Secondary Outcomes (4)

• Physiological measurements - heart rate variability (HRV)

  7-10 days

• Physiological measurements - skin conductance (SC)

  7-10 days

• Physiological measurements - cortisol level

  7-10 days

• Neural measurements

  7-10 days

Study Arms (1)

Behavioral tasks to assess mental states

EXPERIMENTAL

Behavioral: Virtual human social interaction; Behavioral: Cold pressor test

Interventions

Virtual human social interaction BEHAVIORAL

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

Behavioral tasks to assess mental states

Cold pressor test BEHAVIORAL

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.

Behavioral tasks to assess mental states

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

RECRUITING

University of Southern California

Los Angeles, California, 90007, United States

RECRUITING

Study Officials

• Maryam Shanechi, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 7, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Any sharing will happen upon completion of the study and after publication.

Locations

US (2)