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Intracranial Electrodes for Depression

N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age range between 18 and 65
Major depressive disorder (MDD) in a current major depressive episode diagnosed with the Mini-International Neuropsychiatric Interview (MINI)
Must not have
Diffuse epilepsy involving several lobes of the brain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes
Awards & highlights

Summary

This trial aims to show that video-based measures of audio and facial behaviors can provide an objective, continuous measure of internal mood.

Who is the study for?
This trial is for adults aged 18-65 with Major Depressive Disorder currently experiencing a depressive episode. Participants must understand the study and consent independently, without medical or surgical reasons preventing electrode implantation. It's not suitable for those with diffuse epilepsy affecting multiple brain lobes.
What is being tested?
The study tests if audio-facial behaviors captured on video can reliably indicate mood states by correlating them with neural activity via intracranial electrodes. This could lead to better remote monitoring of mood in clinical and home settings.
What are the potential side effects?
While specific side effects are not listed, intracranial electrode placement involves risks such as infection, bleeding, or damage to brain tissue which may result in neurological symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with major depression currently.
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I have no health issues preventing me from getting an electrode implant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My epilepsy affects multiple areas of my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quantitative Audio-Facial Change
Quantitative Mood Change
Secondary study objectives
Correlation between Audio-Facial and Mood Change
Qualitative Mood Change

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Direct electrical stimulation (DES)Active Control1 Intervention
Intracranial electrodes will be used for the delivery of invasive brain stimulation.
Group II: Sham Direct electrical stimulation (DES)Placebo Group1 Intervention
Intracranial electrodes will be used for the delivery of invasive brain stimulation.

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Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,384 Total Patients Enrolled
16 Trials studying Epilepsy
1,213 Patients Enrolled for Epilepsy
~5 spots leftby May 2025
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