Electrophysiologic Studies of Cognition in Epilepsy Patients

NCT05769634 | Completed Results

• 2 other identifiers: STUDY-22-00529R21MH126968-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug-resistant Epilepsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Interoceptive Challenge Battery

EXPERIMENTAL

During simultaneous stereoelectroencephalography recording (n=20) patients will complete a series of three computer-based tasks designed to evoke changes in interoceptive attention and arousal.

Behavioral: Stereoelectroencephalography

Interventions

Stereoelectroencephalography BEHAVIORAL

Computer-based tasks designed to evoke changes in interoceptive attention, arousal and anticipation will be completed. The first asks patients to attend to their heartbeat to manipulate interoceptive attention. The second asks patients to judge affective pictures to manipulate states of arousals. The third engages patients in a probabilistic reward-learning task, or gambling task, and anticipate the outcomes of risky decision-making. A final task guides patients to slow their breathing to 6 breaths per minute.

Interoceptive Challenge Battery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Allison C.Waters
• Organization: Icahn School of Medicine at Mount Sinai

allison.waters@mssm.edu

(212) 523-8832

Study Officials

• Allison Waters

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: August 10, 2022
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to Allison.Waters@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included in the URL field below).

Locations

US (1)