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Stereoelectroencephalography for Epilepsy
Phase < 1
Recruiting
Led By Allison Waters
Research Sponsored by Icahn School of Medicine at Mount Sinai
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 15 minutes
Awards & highlights
Study Summary
This trial uses brain recordings/stimulation to study interoception, which affects a range of clinical symptoms. Outcomes will aid the understanding of abnormal interoception and its effects.
Who is the study for?
This trial is for individuals with drug-resistant epilepsy who may benefit from surgery. They must be undergoing routine surgical management that includes invasive brain activity monitoring, have sufficient hand use for tasks and questionnaires, normal vision or corrected-to-normal vision, and can understand English well enough to follow instructions.Check my eligibility
What is being tested?
The study is using Stereoelectroencephalography (SEEG), an invasive method to record brain activity and stimulate the brain. It aims to understand how we sense internal body signals (interoception) and its link to clinical symptoms like tics or negative mood.See study design
What are the potential side effects?
Since SEEG involves invasive procedures, potential side effects include risks associated with brain surgery such as infection, bleeding, or seizures. There might also be discomfort or other reactions related to the electrodes' placement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heartbeat Evoked Potential (HEP) for arousal
Heartbeat Evoked Potential (HEP) for attention
Heartbeat Evoked Potential (HEP) for decision making
Trial Design
1Treatment groups
Experimental Treatment
Group I: Interoceptive Challenge BatteryExperimental Treatment1 Intervention
During simultaneous stereoelectroencephalography recording (n=30) patients will complete a series of three computer-based tasks designed to evoke changes in interoceptive attention, arousal and anticipation.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,256 Total Patients Enrolled
1 Trials studying Epilepsy
185 Patients Enrolled for Epilepsy
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,119 Total Patients Enrolled
9 Trials studying Epilepsy
5,316 Patients Enrolled for Epilepsy
Allison WatersPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will have or already have 6-8 pairs of SEEG electrodes implanted in my brain.I have epilepsy that might improve with surgery, as advised by specialists.I can use my hands well enough to fill out forms and do tasks.I am taking anti-epileptic drugs, even those with psychiatric side effects.I will have or have had surgery that involved close monitoring.
Research Study Groups:
This trial has the following groups:- Group 1: Interoceptive Challenge Battery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are researchers seeking participants for this research initiative?
"Clinicaltrials.gov indicates that this clinical trial is currently enrolling participants, beginning from its initial posting date of August 10th 2022 and last updated on March 3rd 2023."
Answered by AI
What is the participant cap for this research project?
"Affirmative. According to clinicaltrials.gov, this trial has been recruiting patients since August 10th 2022 and was last revised on March 3rd 2023. Applicants are being sought from one medical centre with 30 places available in total."
Answered by AI
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