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NCT Number: NCT07110688

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Los Amigos National Rehabilitation Center, Downey, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual human social interaction

Behavioral

The participants will perform a social interaction with the virtual human agent platform 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.

Primary outcomes

  1. Positive and Negative Affect Schedule (PANAS)

    Time frame: 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.

  2. Visual Analog Scale (VAS)

    Time frame: 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.

  3. Hamilton Depression Rating Scales (HAMD-6)

    Time frame: 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.

  4. Hamilton Anxiety Rating Scales (HAM-A)

    Time frame: 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.

  5. Immediate Mood Scalar (IMS)

    Time frame: 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.

  6. Fear of Negative Evaluation Brief

    Time frame: 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 outcomes

  1. Physiological measurements - heart rate variability (HRV)

    Time frame: 7-10 days

    Heart rate variability will be collected from each participant by using either commercial systems or the new wearable sensor.

  2. Physiological measurements - skin conductance (SC)

    Time frame: 7-10 days

    Skin conductance will be collected from each participant by using either commercial systems or the new wearable sensor.

  3. Physiological measurements - cortisol level

    Time frame: 7-10 days

    Cortisol level will be collected from each participant by using either commercial systems or the new wearable sensor.

  4. Neural measurements

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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