Novel Multimodal Neural, Physiological, and Behavioral Sensing and Machine Learning for Mental States
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual human social interaction, Cold pressor test.
- Who it may be relevant to
- Registry conditions: No Condition, Study Mental State in Healthy Populations and Drug-resistant Epilepsy Patients With Existing iEEG. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Virtual human social interaction
The participants will perform a social interaction with the virtual human agent platform to assess mental states. - Behavioral 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 measures
- 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]
Secondary outcome measures (4)
- Physiological measurements - heart rate variability (HRV) [Time frame: 7-10 days]
- Physiological measurements - skin conductance (SC) [Time frame: 7-10 days]
- Physiological measurements - cortisol level [Time frame: 7-10 days]
- Neural measurements [Time frame: 7-10 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Rancho Los Amigos National Rehabilitation Center — Downey
- University of Southern California — Los Angeles
Identifiers
NCT: NCT07110688 · R61MH135407 · R61MH135407