NCT05152992

Brief Summary

The overall goal of this study is to elucidate how emotion network dynamics relate to the behavioral, autonomic, and experiential changes that accompany emotions and to investigate how emotion network dysfunction relates to affective symptoms. Affective symptoms are a common feature of neuropsychiatric disorders that reflect dysfunction in a distributed brain network that supports emotion. How aberrant functioning in a single emotion network underlies a wide range of affective symptoms, such as depression and anxiety, is not well understood. Anchored by the anterior cingulate cortex and ventral anterior insula, the emotion network responds to numerous affective stimuli. The recording of neural activity directly from the cortical surface from individuals is a promising approach since intracranial electroencephalography (iEEG) can provide direct estimates of neuronal populations to map the spatiotemporal dynamics of the emotion network at a millisecond level resolution. This study will exam how activity within emotion network hubs changes during emotions and how emotion network properties make some individuals more vulnerable to affective symptoms than others. A multidisciplinary approach is critical for understanding the dynamic brain network to advance neuroanatomical models of emotions and for guiding the development of novel treatments for affective symptoms.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Apr 2015Jun 2026

Study Start

First participant enrolled

April 20, 2015

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

11.2 years

First QC Date

November 29, 2021

Last Update Submit

June 4, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Mean Change from Baseline in Heart Rate

    The mean change from baseline in heart rate is calculated as the average change in heart rate across trials of each emotion video type and stimulated network hub (units: beats/minute). The change from baseline in heart rate on each trial is calculated as: change = (mean heart rate during a trial) - (mean heart rate prior to the trial). Note: this is one of three components of the autonomic nervous system activity outcome measure.

    During inpatient hospitalization, approximately 4-14 days

  • Mean Change from Baseline in Respiratory Rate

    The mean change from baseline in respiratory rate is calculated as the average change in respiratory rate across trials of each emotion video type and stimulated network hub (units: breaths/minute). The change from baseline in respiratory rate on each trial is calculated as: change = (mean respiratory rate during a trial) - (mean respiratory rate prior to the trial). Note: this is one of three components of the autonomic nervous system activity outcome measure.

    During inpatient hospitalization, approximately 4-14 days

  • Mean change from Baseline in Electrodermal Activity

    The mean change from baseline in Electrodermal Activity (EDA) is calculated as the average change in EDA across trials of each emotion video type and stimulated network hub (units: microsiemens).The change from baseline in electrodermal activity on each trial is calculated as: change = (mean electrodermal activity during a trial) - (mean electrodermal activity prior to the trial). Note: this is one of three components of the autonomic nervous system activity outcome measure.

    During inpatient hospitalization, approximately 4-14 days

  • Mean Facial Expression Activity

    Mean facial expression activity (units: activation intensity) is quantified for each video emotion type and stimulated network hub. This is measured using the validated Emotional Facial Action Coding System (FACS) to provide a continuous rating of activity in 28 facial muscles using an intensity scale from 1 (trace) to 5 (maximum). The activity scores of all muscles and across the duration of a trial will be summed to quantify the total facial expression activity of that trial. Trials will be averaged for each video emotion type and stimulated network hub to obtain mean facial expression activity.

    During inpatient hospitalization, approximately 4-14 days

  • Mean Change from Baseline in Neural Activity within the Emotion Network

    The mean change from baseline in neural activity is calculated as the average change in neural activity across trials of each emotion video type and stimulated network hub (units: z-scored neural activity relative to the pretrial baseline). The change from baseline in neural activity on each trial is calculated as: change = (z-scored mean neural activity across the network during a trial) - (z-scored mean neural activity across the network prior to the trial).

    During inpatient hospitalization, approximately 4-14 days

Secondary Outcomes (1)

  • Mean Subjective Experience

    During inpatient hospitalization, approximately 4-14 days

Study Arms (1)

Video and stimulation-based induction of emotion

EXPERIMENTAL

Participants viewed visual stimuli while undergoing stimulation of brain regions involved in emotion during their inpatient hospitalization at the University of California, San Francisco (UCSF).

Behavioral: Viewing visual stimuli and electrical stimulation of the brain

Interventions

View emotionally evocative videos and undergo stimulation of brain regions involved in emotion. In a 20-minute block (5 total blocks), eighteen 30-second movie clips will be used to elicit different categories of emotions (sadness, fear, disgust, awe, affection, and amusement). Additionally, each hub of the emotion network will be stimulated to identify areas that generate similar emotional states as those elicited by the videos. Each stimulation trial consists of 3 minutes of 1-3 mA, 50 Hz, 100 us pulse-width stimulation.

Video and stimulation-based induction of emotion

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with epilepsy at UCSF undergoing surgical electrode implantation for seizure localization and
  • Participants with electrodes implanted in at least two regions of interest who are willing and able to cooperate with study tasks.

You may not qualify if:

  • Participants who lack capacity or decline to provide informed consent,
  • Participants who have significant cerebral lesions or
  • Participants with cognitive deficits that preclude reliable completion of study tasks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

EpilepsyDepressionAnxiety Disorders

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Edward F Chang, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Virginia Sturm, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 10, 2021

Study Start

April 20, 2015

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations