Clinical trial NCT05152992: Spatiotemporal Dynamics of the Human Emotion Network
Official title: Spatiotemporal Dynamics of the Human Emotion Network
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy
Depression
Anxiety
Emotions
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco State University
name: National Institute of Mental Health (NIMH)
First posted: 2021-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Intracranial EEG (iEEG) recordings make it possible to obtain direct measures of emotion network dynamics not possible with other methods. This study proposes to conduct a multimodal assessment of emotions in patients with epilepsy who are undergoing surgery for seizure localization. Electrodes will be placed in sites based on the clinical needs of each patient and will include sites within and outside of the emotion network. The research study team will examine measures of behavior, autonomic nervous system (ANS) activity, and subjective experience to continuous iEEG recordings to determine how emotion network dynamics relate to emotions and affective symptoms. Affective symptoms are common in epilepsy, with nearly one third of patients meeting diagnostic criteria for a severe anxiety or depressive disorder during their lifetimes. This clinical population offers a unique opportunity to obtain direct recordings of emotion network activity with concurrent measures of emotion physiology and behavior. The aims of this study seeks to determine how emotion network activity relates to naturalistic affective behaviors (Aim 1), whether we can uncover the unique neural signatures of discrete emotions and examine their relation to task-based measures of emotional reactivity (Aim 2), and whether electrical stimulation of emotion network changes network activity and alters emotions, mood, and anxiety (Aim 3). Together, these aims will help to uncover the neural mechanisms that produce, sense, and regulate emotions. These results should heavily impact the current understanding of the neurobiological systems that underlie affective symptoms and, therefore, will have significant implications for identifying biomarkers of system dysfunction to guide development of new treatments.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean Change from Baseline in Heart Rate
timeFrame: During inpatient hospitalization, approximately 4-14 days
measure: Mean Change from Baseline in Respiratory Rate
timeFrame: During inpatient hospitalization, approximately 4-14 days
measure: Mean change from Baseline in Electrodermal Activity
timeFrame: During inpatient hospitalization, approximately 4-14 days
measure: Mean Facial Expression Activity
timeFrame: During inpatient hospitalization, approximately 4-14 days
measure: Mean Change from Baseline in Neural Activity within the Emotion Network
timeFrame: During inpatient hospitalization, approximately 4-14 days
Secondary outcomes:
measure: Mean Subjective Experience
timeFrame: During inpatient hospitalization, approximately 4-14 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Edward F Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Virginia Sturm, PhD
role: PRINCIPAL_INVESTIGATOR
References: