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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
Stim_Con Trial 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.Check my eligibility
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.See study design
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.
Stim_Con Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Stim_Con 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
1,590 Previous Clinical Trials
2,281,632 Total Patients Enrolled
7 Trials studying Epilepsy
40,547 Patients Enrolled for Epilepsy
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,679 Total Patients Enrolled
8 Trials studying Epilepsy
5,286 Patients Enrolled for Epilepsy
Adam Goodman, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Acquisition Stimulation Test
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregated quantity of participants involved in this experiment?
"Affirmative, according to the information hosted on clinicaltrials.gov, this research is actively recruiting participants. The announcement of this trial was made on March 1st 2023 and it has been recently updated on May 2nd of the same year. 30 people are required for enrollment at one medical centre."
Answered by AI
Are there still openings available for participants in this clinical trial?
"Absolutely. As per information from clinicaltrials.gov, this investigation is accepting participants at present. It was initially announced on March 1st 2023 and has been revised as of May 2nd 2023. The study needs to enrol 30 individuals across one centre."
Answered by AI
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