Behavioral and Neuronal Correlates of Human Mood States

NCT06159595 | Recruiting DMC FDA Device

• 2 other identifiers: 11354-21R21MH134172
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder; Epilepsy

Outcome Measures

Primary Outcomes (2)

• Quantitative Audio-Facial Change

  Quantitative percent change in each audio-facial feature before and after direct electrical stimulation at each site.

  5 minutes

• Quantitative Mood Change

  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 Outcomes (2)

• Correlation between Audio-Facial and Mood Change

  5 minutes

• Qualitative Mood Change

  5 minutes

Study Arms (2)

Active Direct electrical stimulation (DES)

ACTIVE COMPARATOR

Intracranial electrodes will be used for the delivery of invasive brain stimulation.

Device: Intracranial electrodes

Sham Direct electrical stimulation (DES)

SHAM COMPARATOR

Intracranial electrodes will be used for the delivery of invasive brain stimulation.

Device: Intracranial electrodes

Interventions

Intracranial electrodes DEVICE

Surgically-implanted intracranial electrodes.

Active Direct electrical stimulation (DES); Sham Direct electrical stimulation (DES)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diffuse epilepsy involving several lobes of the brain

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Epilepsy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jade Truong

CONTACT

(408) 840-3313; kellerlab@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 7, 2023
• Study Start: December 1, 2023
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-10

Locations

US (1)