Stereoelectroencephalography for Epilepsy

Overseen By Allison Waters

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Cognitive impairment, Minors, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Interoception, or sensation from inside the body, is involved in a variety of clinical symptoms, such as tics, compulsions and negative mood. This study uses invasive recordings of brain activity and brain stimulation to better understand basic neural mechanisms of interoception and related behaviors. Outcomes of this study provide critical tools for future investigation into clinical symptoms that emerge from abnormal interoception.

Research Team

Allison Waters

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

I can use my hands well enough to fill out forms and do tasks.

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

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

Treatment Details

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.

Participant Groups

Group I: Interoceptive Challenge Battery Experimental Treatment 1 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.

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+