Stimulation-Induced Changes in Fronto-Limbic Network

NCT05854160 | Recruiting

• 2 other identifiers: IRB-3000094341R21MH133055-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods will assess the effects of stimulation before and after conditioning, the results of which will be combined with results from the activity of each electrode during the emotion tasks to inform us of the nature of emotion processing in the brain and allow us to devise brain modulation protocols in the future.

Conditions

Epilepsy; Mental Disorders

Keywords

epilepsy; comorbid mental health disorders; sEEG; Anxiety; Fronto-limbic network; Pavlovian fear conditioning paradigm

Outcome Measures

Primary Outcomes (3)

• Fronto-limbic connectivity and autonomic or expectation responses

  We will test for a positive linear relationship (Pearson r correlation test) between dmPFC to amygdala connectivity values (Granger causality coefficient; sEEG) and physiologic (Skin conductance beta estimates; finger electrodes) and cognitive (self-report; expectancy) threat regulation measures.

  20 Minutes

• Fronto-limbic connectivity strength relation to anxiety symptom severity by conducting between-subjects group-level comparisons

  We will test for a positive linear relationship (Pearson r test) between dmPFC to amygdala effective connectivity values (Granger causality coefficient; sEEG) and measures of anxiety symptom severity (Self-report; Beck Anxiety Inventory \[BAI\])

  20 Minutes

• Anticipatory fronto-limbic connectivity exerting a causal effect on regulation of predictable threat responses using within-subjects group-level comparisons.

  We will test for an effect of stimulation pulse trains (2-sec; sEEG) delivered to the dmPFC by using four (Pre-acquisition stimulation, Pre-acquisition sham, Post-acquisition stimulation, Post-acquisition sham) repeated samples t-tests comparing the factor of Condition (Cue+Threat vs Threat-Alone) on amygdala responses (gamma band power changes; sEEG).

  20 Minutes

Study Arms (1)

Acquisition Stimulation Test

EXPERIMENTAL

Single pulse stimulation will be delivered and measured prior to the rating task. Next, subjects perform the Pavlovian fear conditioning paradigm. Participants will be asked to perform a rating task automated on a PC where they continuously update a rating bar using the touchpad to indicate their confidence that a static sound is about to occur on a moment-by-moment basis (0-not confident to 100-very confident). For the stimulation experiment, research staff will explain that electrical stimulation will be applied before the rating task, in isolation, as well as on some trials at controlled time points while the patient performs the rating task

Procedure: Electrical Pulse Train Stimulation

Interventions

Electrical Pulse Train Stimulation PROCEDURE

sEEG provides the ability to stimulate neural circuits via implanted electrodes by delivering mild intra-cranial electrical stimulations in different brain structures to estimate their impact on cognitive tasks.

Acquisition Stimulation Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) implantation of sEEG electrodes for SOC epilepsy surgery evaluation
• \) cognitive ability to perform simple tasks and to understand instructions
• \) implanted electrodes in the amygdala and medial PFC regions
• \) competency to understand and sign a written informed consent.

You may not qualify if:

• \) an inability to complete the task

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Epilepsy Monitoring Unit UAB Hospital

Birmingham, Alabama, 35233, United States

RECRUITING

Related Publications (2)

• Goodman AM, Harnett NG, Knight DC. Pavlovian conditioned diminution of the neurobehavioral response to threat. Neurosci Biobehav Rev. 2018 Jan;84:218-224. doi: 10.1016/j.neubiorev.2017.11.021. Epub 2017 Dec 2.

  PMID: 29203422 BACKGROUND

• Goodman AM, Wheelock MD, Harnett NG, Davis ES, Mrug S, Deshpande G, Knight DC. Stress-Induced Changes in Effective Connectivity During Regulation of the Emotional Response to Threat. Brain Connect. 2022 Sep;12(7):629-638. doi: 10.1089/brain.2021.0062. Epub 2021 Dec 31.

  PMID: 34541896 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Mental Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Adam Goodman, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebekah Chatfield, BS

CONTACT

(205) 975-3477; joyb3@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 11, 2023
• Study Start: March 1, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): March 24, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be uploaded to the NDA throughout the study but become available 1-2 years after the specified grant end date.
• Access Criteria: Qualified researchers who have completed a Data Use Certification and received approval from the NDA Data Access Committee (DAC) may be approved to access broadly shared data.

Locations

US (1)