- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06159595
Behavioral and Neuronal Correlates of Human Mood States
May 19, 2026 updated by: Corey Keller, Stanford University
Optimizing treatments in mental health requires an easy to obtain, continuous, and objective measure of internal mood.
Unfortunately, current standard-of-care clinical scales are sparsely sampled, subject to recency bias, underutilized, and are not validated for acute mood monitoring.
The recent shift to remote care also requires novel methods to measure internal mood.
Recent advances in computer vision have allowed the accurate quantification of observable speech patterns and facial representations.
The continuous and objective nature of these audio-facial behavioral outputs also enable the study of their neural correlates.
Here, the investigators hypothesize that video-derived audio-facial behaviors have discrete neural representations in the limbic network and can provide a critical set of reliable longitudinal estimates of mood at low cost across home and clinic settings.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age range between 18 and 65
- Major depressive disorder (MDD) in a current major depressive episode diagnosed with the Mini-International Neuropsychiatric Interview (MINI)
- No medical or surgical contraindication to electrode implantation
- Patient capable of understanding the scope of our project or signing informed consent independently.
Exclusion Criteria:
- Diffuse epilepsy involving several lobes of the brain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active Direct electrical stimulation (DES)
Intracranial electrodes will be used for the delivery of invasive brain stimulation.
|
Surgically-implanted intracranial electrodes.
|
|
Sham Comparator: Sham Direct electrical stimulation (DES)
Intracranial electrodes will be used for the delivery of invasive brain stimulation.
|
Surgically-implanted intracranial electrodes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantitative Audio-Facial Change
Time Frame: 5 minutes
|
Quantitative percent change in each audio-facial feature before and after direct electrical stimulation at each site.
|
5 minutes
|
|
Quantitative Mood Change
Time Frame: 5 minutes
|
Quantitative percent change in Immediate Mood Scaler (IMS) after direct electrical stimulation at each site compared to a baseline period before sham.
The minimum score on the IMS is 7 and the maximum is 154, with lower scores reflecting more negative mood states.
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between Audio-Facial and Mood Change
Time Frame: 5 minutes
|
Quantitative audio facial changes will be compared to quantitative changes in mood at each site by means of correlation and binary comparisons.
|
5 minutes
|
|
Qualitative Mood Change
Time Frame: 5 minutes
|
Qualitative articulation of mood (participants freely articulate mood after direct electrical stimulation at each site) and speech transcripts will be analyzed for ratio of positive and negative valence words.
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Actual)
November 7, 2025
Study Completion (Actual)
November 7, 2025
Study Registration Dates
First Submitted
November 16, 2023
First Submitted That Met QC Criteria
December 4, 2023
First Posted (Actual)
December 7, 2023
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 19, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11354-2
- 1R21MH134172 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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