An interventional study of Stereoelectroencephalography in Drug-resistant Epilepsy, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Basic science
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.
Abnormal interoceptive processing is observed across psychiatric and neurological conditions wherein core symptoms are motivated by diffuse bodily feeling: pervasive negative mood in Major Depression, compulsive urge in Obsessive Compulsive Disorder, urge to tic in Tourette Syndrome, and craving in addiction. Despite the prevalence of interoceptive abnormality, there is a scarcity of data on neurovisceral interactions in clinical populations. This knowledge gap can be attributed in part to a need for objective, neural measures of interoceptive processing. A candidate neural measure is the heartbeat evoked potential (HEP), a brain electrophysiological signal that is time-locked to the heartbeat and thought to index baroreceptor sensation in the chest cavity. While promising, basic characteristics of this signal are unknown, which limits its application to mechanistic and clinical research. Cortical sources of the HEP have been identified in the insula, yet spatial and temporal characteristics diverge across experimental paradigms. This suggests multiple functional correlates and cortical sources of the HEP index, including the insula. An added challenge is that the insula may be too deep for non-invasive recording and modulation, which necessitates invasive neural recording to explain non-invasive measures. Aim 1 validates neural source generators of the HEP with simultaneous invasive stereoelectroencephalography and dense array EEG on the scalp surface, while patients complete a battery of interoceptive tasks. Aim 2 investigates neural network dynamics during interoceptive attention, arousal and anticipation: theorizing that key clinical symptoms (e.g., tic, compulsions, negative mood) are learned behaviors in response to interoceptive cues, the research team tests the specific hypothesis that interoceptive activity is a predictor of reward-based decisions, particularly when decision-making demands a go with your gut strategy as reward outcomes are learned. Critically, Aim 3 then applies a deep breathing strategy to strategically perturb cardiac dynamics and disambiguate functional correlates of the HEP signal. Outcomes define properties of the HEP signal that must be known for this measurement strategy to inform and validate models of abnormal interoceptive circuit dynamics involving maladaptive responses to bodily distress.
261 studies on the registry are indexed under Drug Resistant Epilepsy; 99 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 208 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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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:
Exclusion Criteria:
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
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.
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.
Time frame: 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.
Time frame: 15 minutes
| Milestone | Interoceptive Challenge Battery |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| µV | Interoceptive Challenge Battery |
|---|---|
| Heartbeat Evoked Potential (HEP) for Attention | -1.5 (-2.9 to -0.1) |
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.
| µV | Interoceptive Challenge Battery |
|---|---|
| Heartbeat Evoked Potential (HEP) for Arousal | -2.02 (-3.15 to -0.89) |
Collected over Adverse event data were collected during the 15-minute period of stereoelectroencephalography recording.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interoceptive Challenge Battery | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Interoceptive Challenge Battery |
|---|---|
| Mean | 37 ± 15 |
| Sex: Female, Male(Participants) | Interoceptive Challenge Battery |
|---|---|
| Female | 11 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Interoceptive Challenge Battery |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 16 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Interoceptive Challenge Battery |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 9 |
| White | 8 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap, Csr, Analytic code
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Icahn School of Medicine at Mount Sinai