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EpilepsyStim_ConNCT05854160

Stimulation-Induced Changes in Fronto-Limbic Network

A study testing Electrical Pulse Train Stimulation in people with Epilepsy and Mental Disorders, run by University of Alabama at Birmingham at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epilepsy, Mental Disorders
What is being tested?
Electrical Pulse Train Stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Mar 2023to 24 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 1) an inability to complete the task

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rebekah Chatfield, BS contact

(205) 975-3477

joyb3@uab.edu

United States1 site, 1 recruiting
  • Epilepsy Monitoring Unit UAB Hospital

    Birmingham, Alabama, 35233

    Rebekah Chatfield, BS, (205) 975 3477, Joyb3@uab.edu

    Adam Goodman, PhD

    Recruiting

Other trials in United States

About this study

Official title: Stimulation-Induced Changes in Fronto-Limbic Connectivity Control Regulation of the Emotional Response to Threat

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.

Read the detailed description

About half of the 70M persons with epilepsy (PWE) worldwide will suffer from comorbid mental health disorders (MHDs), with depression and anxiety estimated to be the most prevalent. MHDs and epilepsy each pose significant barriers to work, social functioning, physical disability, and increased risk of mortality. While pathophysiology of epilepsy and anxiety involves similar brain circuits, identifying specific network disruptions that cause emotion regulation dysfunction would critically inform treatment targets for both conditions. Disruptions in the fronto-limbic network (i.e., prefrontal cortex; cingulate cortex; insula; hippocampus; amygdala) are linked to anxiety disorders and impaired emotion response regulation. Likewise, epilepsies are associated with aberrant fronto-limbic function and connectivity that underlie emotion processing. Further, emotion regulation and anxiety symptom severity improve with better seizure control and vice versa. Despite this converging evidence, fronto-limbic circuit disruption that modulates emotion regulation dysfunction in PWE and MHDs remains poorly understood. The goal of the proposed pilot work is to test whether stimulation of specific brain regions modulates the function and connectivity of these networks as well as corresponding regulation of emotional responses. I will achieve the goal of this study by harnessing the novel and innovative approach of stereoelectroencephalography (sEEG) available in UAB's epilepsy monitoring unit as part of standard of care among epilepsy surgery candidates.

Neural recordings that map human brain function underlying behavior and cognition have provided substantial insights into the organization of brain networks and have provided a springboard for launching investigations into developing new interventions. Further, invasive neural recordings in humans provide an unparalleled window into neural circuitry underlying complex moods, emotions, cognition, and behaviors with high spatial and temporal resolution. Assessment of neural circuity underlying these important functions is also critical for the best clinical care of patients undergoing resective surgery to treat epilepsy. In particular, sEEG is a minimally invasive clinical procedure in which electrodes are surgically implanted into the brain in order to better localize the seizure focus. During the post-implantation period, sEEG records directly from an array of depth electrodes implanted throughout the brain to capture spatio-temporal transitions within broadly distributed functional brain networks on a finer neuroanatomical (millimeter) and temporal (millisecond) scale than possible with relatively abundant and standard functional neuroimaging (e.g., fMRI) and electrophysiology techniques (e.g., EEG). Additionally, sEEG provides the ability to stimulate those circuits via the same electrodes by delivering mild intra-cranial electrical stimulations in different brain structures to estimate their impact on cognitive tasks. Thus, sEEG serves as a powerful tool to explore the neural circuitry underlying complex moods, emotions, cognition, and behaviors via non-stimulation recordings for establishing correlations among brain function, connectivity, and behavior, as well as mapping stimulation-manipulated brain-behavior relationships. However, limited applications have been utilized to date for studies of emotion processes. Pavlovian fear conditioning is an effective and widespread paradigm often used in both human and non-human animal models to study emotional learning, memory, and regulation processes. In a typical Pavlovian fear conditioning paradigm, a warning cue, also called a conditioned stimulus (CS+), is paired with a threat (e.g., 100 db static sound, 0.5s), also called an unconditioned stimulus (UCS). A distinct safety cue (CS-) can also be paired with the absence of a threat. After repeated pairings of these stimuli (conditioning trials), only the warning cue begins to produce a conditioned response (CR). The CR is often taken as evidence that the association between the warning cue and threat has been learned. However, learning-related changes in the response to threat, also called the unconditioned response (UCR), are frequently observed. Conditioned diminution of the response to threat is demonstrated by a diminished emotional threat response (e.g., skin conductance) when the threat follows a warning cue (i.e., predictable threat) compared to when a threat follows a safety cue or is presented alone (i.e., unpredictable threat). This conditioned diminution of the threat response provides a continuous measure of the ability to regulate the emotional response to threat. Further, this paradigm has been utilized by our study team to report function and connectivity of the fronto-limbic network correlated with inhibition of emotion responses in healthy controls using fMRI. However, assessing experimenter-induced changes in function, connectivity, and behavior via stimulation of the fronto-limbic brain regions would provide the critical next step of a more rigorous test of the causal hypotheses regarding this brain-behavior relationship.

Temporal lobe epilepsy (TLE) is the most common form of treatment resistant epilepsy. Patients with TLE frequently undergo sEEG evaluation for possible resective surgery and they are an ideal study population to assess brain-behavior relations in emotion processes. TLE is also characterized by a high rate of anxiety disorder comorbidity and is associated with dysfunction within the fronto-limbic circuit underlying emotion processes. The comorbidity between epilepsy and anxiety may arise due to a large degree of overlapping changes within fronto-limbic network that are linked to symptoms of anxiety. Specifically, frontal lobe connectivity with medial temporal regions (i.e., prefrontal cortex; cingulate cortex; hippocampus; amygdala) via the cingulum bundle is an important network involved in seizure propagation and TLE comorbidities, including anxiety disorders. Likewise, neuroimaging studies (i.e., fMRI) have demonstrated correlations between emotion regulation and function within this fronto-limbic network. Yet, existing neuroimaging and electrophysiology techniques are limited in their assessment of experimenter-manipulated brain-behavior relationships due to correlational approaches, in addition to poor temporal resolution (1-3 s TR in fMRI) and spatial specificity (broad cortical assessment in EEG). Thus, fronto-limbic sEEG mapping will serve as a valuable assessment of function and connectivity modulating inhibition of emotion responses before and after Pavlovian fear conditioning. By also conducting mental health assessments in these patients, this project will serve as a valuable model for better understanding network function linked to epilepsy, anxiety, and healthy emotion processes.

Being tested
Electrical Pulse Train Stimulation
Keywords
epilepsy, comorbid mental health disorders, sEEG, Anxiety, Fronto-limbic network, Pavlovian fear conditioning paradigm
Medical subject headings
Epilepsy, Mental Disorders, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrical Pulse Train StimulationProcedure or surgery

    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.

Study groups in NCT05854160
Study groupRoleWhat they receive
Acquisition Stimulation TestExperimentalSingle 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
Receives: Procedure: Electrical Pulse Train Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 20 Minutes

  2. 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])

    Measured: 20 Minutes

  3. 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).

    Measured: 20 Minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start1 Mar 2023
  3. Primary completion28 Feb 2026
  4. Study completion24 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05854160
Sponsor's protocol ID
IRB-300009434
Other IDs
1R21MH133055-01
Acronym
Stim_Con
Status last verified
Feb 2026
First submitted
20 Apr 2023
Last updated
23 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: NIMH Data Archive (NDA)

Publications

  • 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.

    PubMed 29203422
  • 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.

    PubMed 34541896

Questions about this trial

What is this clinical trial studying?

A study testing Electrical Pulse Train Stimulation in people with Epilepsy and Mental Disorders, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rebekah Chatfield, BS ((205) 975-3477, joyb3@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fronto-limbic connectivity and autonomic or expectation responses (time frame: 20 Minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05854160, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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