Behavioral and Neuronal Correlates of Human Mood States

Not Applicable

Recruiting

• Conditions: Epilepsy; Major Depressive Disorder
• Interventions: Device: Intracranial electrodes

• Registration Number: NCT06159595
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-16
• Study Start: 2023-12-01
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Direct electrical stimulation (DES)	Intracranial electrodes	Intracranial electrodes will be used for the delivery of invasive brain stimulation.
Sham Direct electrical stimulation (DES)	Intracranial electrodes	Intracranial electrodes will be used for the delivery of invasive brain stimulation.

Primary Outcome Measures

Name	Time	Method
Quantitative Mood Change	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.
Quantitative Audio-Facial Change	5 minutes	Quantitative percent change in each audio-facial feature before and after direct electrical stimulation at each site.

Secondary Outcome Measures

Name	Time	Method
Correlation between Audio-Facial and Mood Change	5 minutes	Quantitative audio facial changes will be compared to quantitative changes in mood at each site by means of correlation and binary comparisons.
Qualitative Mood Change	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States