Stereoelectroencephalography for Epilepsy

AW
Overseen ByAllison Waters
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the brain senses signals from inside the body, affecting symptoms like tics, compulsions, and mood changes. Researchers use stereoelectroencephalography, which records and stimulates brain activity, to gain a deeper understanding of these processes. The study targets individuals with medication-resistant epilepsy who may require brain surgery. Those already undergoing invasive monitoring as part of their epilepsy treatment and capable of completing tasks and questionnaires may be suitable participants. The findings could enhance understanding and treatment of symptoms caused by abnormal internal body signals. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could lead to new insights and treatments for epilepsy-related symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that using anti-epileptic drugs (AEDs) with known psychiatric complications is allowed, so you might be able to continue those.

What prior data suggests that stereoelectroencephalography is safe for epilepsy?

Research has shown that stereoelectroencephalography (SEEG) is generally safe for people with epilepsy. In studies involving over 6,000 patients with medication-resistant epilepsy, SEEG resulted in low complication rates, indicating that serious side effects were rare. One study found that procedures guided by SEEG were safe, with only temporary muscle weakness reported in some cases. These findings suggest that SEEG is well-tolerated and rarely causes lasting problems.12345

Why are researchers excited about this trial?

Researchers are excited about using stereoelectroencephalography (SEEG) for epilepsy because it offers a unique way to understand and treat seizures by directly monitoring brain activity. Unlike standard treatments like anti-seizure medications or surgical resections, SEEG involves implanting electrodes in the brain to precisely map seizure origins. This precise mapping can help tailor treatment plans that are highly specific to each patient's needs, potentially leading to more effective and personalized management of epilepsy. By capturing the brain's electrical activity in real-time during tasks designed to change interoceptive attention and arousal, SEEG can provide new insights into how seizures start and spread, paving the way for innovative therapeutic approaches.

What evidence suggests that stereoelectroencephalography is effective for epilepsy?

Research has shown that stereoelectroencephalography (SEEG), a technique participants in this trial will undergo, effectively pinpoints the brain area causing seizures in people with epilepsy. This precision aids doctors in planning better treatments, often leading to improved outcomes. Studies have found that SEEG has helped many patients become seizure-free or experience fewer seizures. Even when MRI scans fail to provide clear answers, SEEG can still offer useful information. Overall, SEEG serves as a valuable tool for understanding and treating epilepsy, especially when other methods fall short.36789

Who Is on the Research Team?

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Allison Waters

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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.

Inclusion 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.
Normal or corrected to normal vision, determined by patient report
See 3 more

Exclusion Criteria

Pre-operative neuropsychological testing indicates a Montreal Cognitive Assessment (MOCA) score < 26
English language proficiency insufficient to complete psychometric questionnaires and receive task instructions (<6th grade reading level) as determined by neuropsychologist at pre-operative assessment
Vulnerable populations such as minors, pregnant women, cognitive impaired individuals, and prisoners will not be included in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Interoceptive Challenge Battery

Participants undergo simultaneous stereoelectroencephalography recording while completing tasks to evoke changes in interoceptive attention, arousal, and anticipation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the interoceptive challenge battery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Stereoelectroencephalography
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Interoceptive Challenge BatteryExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Seizure outcomes and complications associated with ...Our analysis utilized data from 81 articles, representing 6,274 patients with drug-resistant epilepsy who underwent either SEEG or SDE for ...
Stereoelectroencephalography for Epilepsy Presurgical ...Whole cohort results show a high proportion of nonlesional MRI cases achieving satisfactory surgical outcomes and evolution to increased RF-TC ...
What We've Learned From Our First 1,000 SEEG CasesNotably, SEEG was found to be comparably effective in patients with frontal and temporal lobe epilepsy and in patients with or without MRI- ...
The role of stereo-electroencephalography to localize ...Evaluation by SEEG implantation in pediatric epilepsy is effective in localizing the epileptogenic zone with favorable outcome.
SEEG in 2025: progress and pending challenges in stereotaxy ...A 2018 systematic review of six studies and 296 patients has reported an overall 50% responder rate of 58% and seizure-free rate of 23% at 1 ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38021558/
A Systematic Review and Meta-Analysis of Safety ...This comprehensive analysis underscores the safety and efficacy of RA-SEEG in patients with medication-refractory epilepsy, characterized by low complication ...
Seizure outcomes and complications associated with ...Our analysis utilized data from 81 articles, representing. 6,274 patients with drug-resistant epilepsy who underwent either. SEEG or SDE for ...
Safety and efficacy of stereoelectroencephalography using a ...The authors demonstrated that there was no statistical difference in epilepsy outcomes between robot-assisted SEEG and navigation-based SEEG ...
Stereo-electroencephalography-guided radiofrequency ...SEEG-guided RFTC achieved 75.8% response and 51.5% seizure freedom in pediatric MRI-negative epilepsy. · The procedure was safe; only transient muscle weakness ...
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