Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT05854160

Conditions

Epilepsy

Mental Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electrical Pulse Train Stimulation

Study Details

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

Study ID

NCT05854160

Start date

Mar 1, 2023

Status verified date

Feb, 2026

Completion date

Feb 24, 2027

Anticipated

Primary completion date

Feb 28, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 1\) an inability to complete the task

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Acquisition Stimulation Test

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

Interventions

Electrical Pulse Train Stimulation

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.

Primary outcome measure

  • Fronto-limbic connectivity and autonomic or expectation responses [ Time Frame: 20 Minutes ]
  • Fronto-limbic connectivity strength relation to anxiety symptom severity by conducting between-subjects group-level comparisons [ Time Frame: 20 Minutes ]
  • Anticipatory fronto-limbic connectivity exerting a causal effect on regulation of predictable threat responses using within-subjects group-level comparisons. [ Time Frame: 20 Minutes ]

Central Contacts and Locations

Central contacts

Rebekah Chatfield, BS

(205) 975-3477joyb3@uab.edu

Locations

Epilepsy Monitoring Unit UAB Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Rebekah Chatfield, BS

(205) 975 3477Joyb3@uab.edu

Principal Investigator:

Adam Goodman, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 23, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-23.