Drug-resistant Epilepsy Clinical Trial
Official title:
Electrophysiological Read-Out of Interoceptive Processing in the Insula
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 | Recruiting |
Enrollment | 30 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai West | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heartbeat Evoked Potential (HEP) for attention | The heartbeat evoked potential is a brain electrophysiological signal time locked to the "rpeak" of the cardiac signal and thought to reflect interoceptive sensation of baroreceptor firing in the chest cavity. The population average magnitude of the change in HEP following the experimental manipulation (mean, standard deviation, 95% confidence interval) will be reported. | 15 minutes | |
Primary | Heartbeat Evoked Potential (HEP) for arousal | The heartbeat evoked potential is a brain electrophysiological signal time locked to the "rpeak" of the cardiac signal and thought to reflect interoceptive sensation of baroreceptor firing in the chest cavity. The population average magnitude of the change in HEP following the experimental manipulation (mean, standard deviation, 95% confidence interval) will be reported. | 15 minutes | |
Primary | Heartbeat Evoked Potential (HEP) for decision making | The heartbeat evoked potential is a brain electrophysiological signal time locked to the "rpeak" of the cardiac signal and thought to reflect interoceptive sensation of baroreceptor firing in the chest cavity. The population average magnitude of the change in HEP following the experimental manipulation (mean, standard deviation, 95% confidence interval) will be reported. | 15 minutes |
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