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Electrical Stimulation for Mental Health Conditions (Stim_Con Trial)

N/A
Recruiting
Led By Adam Goodman, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial will use brain recording and stimulation to study how emotion processing works. Results will create protocols for future brain modulation.

Who is the study for?
This trial is for individuals with epilepsy who are undergoing standard-of-care (SOC) surgery evaluation and have the cognitive ability to perform tasks and understand instructions. Participants must have electrodes implanted in specific brain regions (amygdala and medial PFC) and be able to consent.
What is being tested?
The study investigates how emotions are processed in the brain using a technique called stereoelectroencephalography (sEEG) combined with electrical pulse train stimulation. It involves behavioral tasks, neural recording, and direct brain stimulation before and after conditioning.
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort or adverse reactions from electrical stimulation, such as headaches or temporary changes in mood or cognition due to the targeted nature of the intervention.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anticipatory fronto-limbic connectivity exerting a causal effect on regulation of predictable threat responses using within-subjects group-level comparisons.
Fronto-limbic connectivity and autonomic or expectation responses
Fronto-limbic connectivity strength relation to anxiety symptom severity by conducting between-subjects group-level comparisons

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Acquisition Stimulation TestExperimental Treatment1 Intervention
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

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,647 Previous Clinical Trials
2,342,376 Total Patients Enrolled
7 Trials studying Epilepsy
40,547 Patients Enrolled for Epilepsy
National Institute of Mental Health (NIMH)NIH
2,927 Previous Clinical Trials
2,744,807 Total Patients Enrolled
10 Trials studying Epilepsy
5,376 Patients Enrolled for Epilepsy
Adam Goodman, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Epilepsy Research Study Groups: Acquisition Stimulation Test
Acquisition Stimulation Test 2023 Treatment Timeline for Medical Study. Trial Name: NCT05854160 — N/A
~3 spots leftby Feb 2025
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