Drug-resistant EpilepsyNCT05769634
Electrophysiologic Studies of Cognition in Epilepsy Patients
A study testing Stereoelectroencephalography in people with Drug-resistant Epilepsy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-resistant Epilepsy
- What is being tested?
- Stereoelectroencephalography
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2022to 28 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Drug-resistant Epilepsy
- Being tested
- Stereoelectroencephalography
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StereoelectroencephalographyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Stereoelectroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start10 Aug 2022
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug-resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Allison Waters, Icahn School of Medicine at Mount Sinai
- Investigators
- Allison Waters, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769634
- Sponsor's protocol ID
- STUDY-22-00529
- Other IDs
- R21MH126968-01A1
- Status last verified
- Jun 2025
- First submitted
- 3 Mar 2023
- Last updated
- 26 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiologic Studies of Cognition in Epilepsy Patients
- ClinicalTrials.gov ID
- NCT05769634
- Acronym / sponsor ID
- STUDY-22-00529
- Conditions
- Drug-resistant Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interoceptive Challenge Battery | Experimental | Behavioral: StereoelectroencephalographyDuring simultaneous stereoelectroencephalography recording (n=20) patients will complete a series of three computer-based tasks designed to evoke changes in interoceptive attention and arousal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StereoelectroencephalographyComputer-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. | Behavioural | Interoceptive Challenge Battery |
Primary outcome
Heartbeat Evoked Potential (HEP) for Attention
Time frame: 15 minutes
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.
Heartbeat Evoked Potential (HEP) for Arousal
Time frame: 15 minutes
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Waters principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereoelectroencephalography in people with Drug-resistant Epilepsy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heartbeat Evoked Potential (HEP) for Attention (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.