Trial Outcomes & Findings for Electrophysiologic Studies of Cognition in Epilepsy Patients (NCT NCT05769634)

Last Updated: 2025-06-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

15 minutes

Results posted on

2025-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Interoceptive Challenge Battery 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. Stereoelectroencephalography: 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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrophysiologic Studies of Cognition in Epilepsy Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interoceptive Challenge Battery n=20 Participants During simultaneous stereoelectroencephalography recording (n=20) patients will complete a series of three computer-based tasks designed to evoke changes in interoceptive attention, arousal and anticipation. Stereoelectroencephalography: Three 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. A final task guides patients to slow their breathing to 6 breaths per minute.
Age, Continuous	37 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Outcome measures

Outcome measures
Measure	Interoceptive Challenge Battery n=20 Participants During simultaneous stereoelectroencephalography recording (n=20) patients will complete a series of three computer-based tasks designed to evoke changes in interoceptive attention, arousal and anticipation. Stereoelectroencephalography: Three 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. A final task guides patients to slow their breathing to 6 breaths per minute.
Heartbeat Evoked Potential (HEP) for Attention	-1.5 µV Interval -2.9 to -0.1

PRIMARY outcome

Timeframe: 15 minutes

Outcome measures

Outcome measures
Measure	Interoceptive Challenge Battery n=20 Participants During simultaneous stereoelectroencephalography recording (n=20) patients will complete a series of three computer-based tasks designed to evoke changes in interoceptive attention, arousal and anticipation. Stereoelectroencephalography: Three 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. A final task guides patients to slow their breathing to 6 breaths per minute.
Heartbeat Evoked Potential (HEP) for Arousal	-2.02 µV Interval -3.15 to -0.89

Adverse Events

Interoceptive Challenge Battery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allison C.Waters

Icahn School of Medicine at Mount Sinai

Phone: (212) 523-8832

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place