No Condition, Study Mental State in Healthy Populations and Drug-resistant Epilepsy Patients With Existing iEEG
Conditions
Keywords
neurotechnology, neuropsychiatric disorders, brain-machine interface
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.
Interventions
BEHAVIORALVirtual human social interaction
The participants will perform a social interaction with the virtual human agent platform to assess mental states.
BEHAVIORALCold 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.
Sponsors
National Institute of Mental Health (NIMH)
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed