NCT05769634Completed
Electrophysiologic Studies of Cognition in Epilepsy Patients
Source: ClinicalTrials.gov · Last updated 26 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 3 Mar 2023
- Start date
- 10 Aug 2022
- Primary completion date
- 28 May 2024
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Epilepsy
- NCT number
- NCT05769634
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 10 Aug 2022 to the primary completion date, 28 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- Epileptologists at Mount Sinai West have identified the patient as having drug-resistant epilepsy that may benefit from surgery
- Patient has or will undergo invasive monitoring as part of routine surgical management
- Patient has or will be implanted with a minimum of 6-8 bilateral SEEG pairs, including posterior and anterior insula, and at least four of the following targets:
- ventral lateral prefrontal cortex
- dorsal medial prefrontal cortex
- mid-cingulate
- subcallosal cingulate
- amygdala
- hippocampus
- fusiform gyrus
- Sufficient use of hands to complete self-report questionnaires and tasks, as determined during pre-surgical neuropsychological assessment
- Normal or corrected to normal vision, determined by patient report
- Use of anti-epileptic drugs (AEDs) with known psychiatric complications will not be an exclusion criterion
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai West Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.