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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 weeks
Treatment ~ Varies
Follow Up ~15 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes for reporting.

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.

Find a Location

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

Stereoelectroencephalography Clinical Trial Eligibility Overview. Trial Name: NCT05769634 — Phase < 1
Epilepsy Research Study Groups: Interoceptive Challenge Battery
Epilepsy Clinical Trial 2023: Stereoelectroencephalography Highlights & Side Effects. Trial Name: NCT05769634 — Phase < 1
Stereoelectroencephalography 2023 Treatment Timeline for Medical Study. Trial Name: NCT05769634 — Phase < 1

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
~11 spots leftby Apr 2025