Stimulation-Induced Changes in Fronto-Limbic Network
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
1) an inability to complete the task
Trial design
Design model
Single group
Treatments tested in this trial
Electrical Pulse Train Stimulation
Procedure/SurgerysEEG 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Acquisition Stimulation TestExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
20 Minutes2
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 \[BAI\])
Time frame
20 Minutes3
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).
Time frame
20 MinutesSponsors and contacts
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University of Alabama at Birmingham
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov