No ConditionNCT07110688
Novel Multimodal Neural, Physiological, and Behavioral Sensing and Machine Learning for Mental States
A study testing Virtual human social interaction and Cold pressor test in people with No Condition and Study Mental State in Healthy Populations and Drug-resistant Epilepsy Patients With Existing iEEG, run by University of Southern California at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- No Condition, Study Mental State in Healthy Populations and Drug-resistant Epilepsy Patients With Existing iEEG
- What is being tested?
- Virtual human social interaction and Cold pressor test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2024to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Charles Liu, MD, PhD, 323-226-7421, cliu@usc.edu
- Recruiting
University of Southern California
Los Angeles, California, 90007
Maryam M Shanechi, PhD, 213-740-1377, shanechi@usc.edu
HyeongChan Jo, PhD, hj_380@usc.edu
About this study
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
- Being tested
- Virtual human social interaction, Cold pressor test
- Keywords
- neurotechnology, neuropsychiatric disorders, brain-machine interface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual human social interactionBehavioural
The participants will perform a social interaction with the virtual human agent platform to assess mental states.
Cold pressor testBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral tasks to assess mental states | Experimental | Not described Receives: Behavioral: Virtual human social interaction; Behavioral: Cold pressor test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7-10 days
Secondary outcomes (4)
Physiological measurements - heart rate variability (HRV)
Heart rate variability will be collected from each participant by using either commercial systems or the new wearable sensor.
Measured: 7-10 days
Physiological measurements - skin conductance (SC)
Skin conductance will be collected from each participant by using either commercial systems or the new wearable sensor.
Measured: 7-10 days
Physiological measurements - cortisol level
Cortisol level will be collected from each participant by using either commercial systems or the new wearable sensor.
Measured: 7-10 days
Neural measurements
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.
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Aug 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Maryam Shanechi, University of Southern California
- Investigators
- Maryam Shanechi, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110688
- Sponsor's protocol ID
- R61MH135407
- Other IDs
- R61MH135407
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study and after publication, fully de-identified IPD may be made available for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Multimodal Neural, Physiological, and Behavioral Sensing and Machine Learning for Mental States
- ClinicalTrials.gov ID
- NCT07110688
- Acronym / sponsor ID
- R61MH135407
- Conditions
- No Condition, Study Mental State in Healthy Populations and Drug-resistant Epilepsy Patients With Existing iEEG
- Keywords
- neurotechnology, neuropsychiatric disorders, brain-machine interface
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral tasks to assess mental states | Experimental | Behavioral: Virtual human social interaction, Behavioral: Cold pressor test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual human social interactionThe participants will perform a social interaction with the virtual human agent platform to assess mental states. | Behavioural | Behavioral tasks to assess mental states |
| Cold pressor testHealthy 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. | Behavioural | Behavioral tasks to assess mental states |
Primary outcome
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.
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.
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.
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.
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Yes. Upon completion of the study and after publication, fully de-identified IPD may be made available for research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maryam Shanechi, PhD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual human social interaction and Cold pressor test in people with No Condition and Study Mental State in Healthy Populations and Drug-resistant Epilepsy Patients With Existing iEEG, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Affect Schedule (PANAS) (time frame: 7-10 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025; AzTrials last refreshed its copy on 29 Oct 2026.