Behavioral and Neuronal Correlates of Human Mood States

Major Depressive Disorder Clinical Trial

Official title:

Behavioral and Neuronal Correlates of Human Mood States

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159595
• Other study ID #: 11354-2
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Jade Truong
• Phone: (408) 840-3313
• Email: kellerlab[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Epilepsy
• Major Depressive Disorder

Intervention

Device:
• Intracranial electrodes
Surgically-implanted intracranial electrodes.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative Audio-Facial Change	Quantitative percent change in each audio-facial feature before and after direct electrical stimulation at each site.	5 minutes
Primary	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	Correlation between Audio-Facial and Mood Change	Quantitative audio facial changes will be compared to quantitative changes in mood at each site by means of correlation and binary comparisons.	5 minutes
Secondary	Qualitative Mood Change	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