NCT05854160 · University of Alabama at Birmingham
Stimulation-Induced Changes in Fronto-Limbic Network
(Stim_Con)
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
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 measures
Fronto-limbic connectivity and autonomic or expectation responses
Time frame: 20 Minutes
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.
Fronto-limbic connectivity strength relation to anxiety symptom severity by conducting between-subjects group-level comparisons
Time frame: 20 Minutes
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 \[BAI\])
Anticipatory fronto-limbic connectivity exerting a causal effect on regulation of predictable threat responses using within-subjects group-level comparisons.
Time frame: 20 Minutes
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
Collaborators
National Institute of Mental Health (NIMH)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations