Behavioral and Neuronal Correlates of Human Mood States

NCT ID: NCT06159595

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-10-30

Brief Summary

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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

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Conditions

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Major Depressive Disorder Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Active Direct electrical stimulation (DES)

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

Group Type ACTIVE_COMPARATOR

Intracranial electrodes

Intervention Type DEVICE

Surgically-implanted intracranial electrodes.

Sham Direct electrical stimulation (DES)

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

Group Type SHAM_COMPARATOR

Intracranial electrodes

Intervention Type DEVICE

Surgically-implanted intracranial electrodes.

Interventions

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Intracranial electrodes

Surgically-implanted intracranial electrodes.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Corey Keller

Principal Investigator, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jade Truong

Role: CONTACT

(408) 840-3313

Facility Contacts

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Jade Truong

Role: primary

Other Identifiers

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1R21MH134172

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11354-2

Identifier Type: -

Identifier Source: org_study_id

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