EpilepsyNCT05283811
Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients
A study testing NEUROPACE RNS SYSTEM and EMU in people with Epilepsy, run by Baylor College of Medicine at 3 sites in United States.
Trial summary
Humans have a remarkable ability to flexibly interact with the environment. A compelling demonstration of this cognitive flexibility is human's ability to respond correctly to novel contextual situations on the first attempt, without prior rehearsal. Read more about this study
- Who is it for?
- Ages 10 to 64 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- NEUROPACE RNS SYSTEM and EMU
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2021to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Eligible subjects include both male and female patients, between 10 years of age and 64 years of age, who undergo placement of intracranial electrodes for clinical characterization of epilepsy.
Who cannot join
- Grounds for exclusion would include inability to understand and follow instructions, or inability to concentrate sufficiently to achieve a high proportion of correct responses.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Victoria Pirtle, 713-798-1717, victoria.pirtle@bcm.edu
Sameer A Sheth, MD, PhD, 713-798-5060, sameer.sheth@bcm.edu
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Nanthia Suthana
- Active, not recruiting
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Mapping Algorithmic State Space in the Human Brain
Humans have a remarkable ability to flexibly interact with the environment. A compelling demonstration of this cognitive flexibility is human's ability to respond correctly to novel contextual situations on the first attempt, without prior rehearsal. The investigators refer to this ability as 'ad hoc self-programming': 'ad hoc' because these new behavioral repertoires are cobbled together on the fly, based on immediate demand, and then discarded when no longer necessary; 'self-programming' because the brain has to configure itself appropriately based on task demands and some combination of prior experience and/or instruction. The overall goal of our research effort is to understand the neurophysiological and computational basis for ad hoc self-programmed behavior. The previous U01 project (NS 108923) focused on how these programs of action are initially created. The results thus far have revealed tantalizing notions of how the brain represents these programs and navigates through the programs. In this proposal, therefore, the investigators focus on the question of how these mental programs are executed. Based on the preliminary findings and critical conceptual work, the investigators propose that the medial temporal lobe (MTL) and ventral prefrontal cortex (vPFC) creates representations of the critical elements of these mental programs, including concepts such as 'rules' and 'locations', to allow for effective navigation through the algorithm. These data suggest the existence of an 'algorithmic state space' represented in medial temporal and prefrontal regions. This proposal aims to understand the neurophysiological underpinnings of this algorithmic state space in humans. By studying humans, the investigators will profit from our species' powerful capacity for generalization to understand how such state spaces are constructed. The investigators therefore leverage the unique opportunities available in human neuroscience research to record from single cells and population-level signals, as well as to use intracranial stimulation for causal testing, to address this challenging problem. In Aim 1 the investigators study the basic representations of algorithmic state space using a novel behavioral task that requires the immediate formation of unique plans of action. Aim 2 directly compares representations of algorithmic state space to that of physical space by juxtaposing balanced versions of spatial and algorithmic tasks in a virtual reality (VR) environment. Finally, in Aim 3, the investigators test hypotheses regarding interactions between vPFC and MTL using intracranial stimulation.
- Conditions
- Epilepsy
- Being tested
- NEUROPACE RNS SYSTEM, EMU
- Keywords
- Single-neuron, Local-field potentials
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUROPACE RNS SYSTEMDevice
This device is indicated as a therapy in reducing the frequency of seizures in individuals
EMUBehavioural
Patients are admitted to the Epilepsy Monitoring Unit for observation of seizure activity prior to further treatment
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy Monitoring Unit | Other | Patient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit Receives: Behavioral: EMU |
| Neuropace RNS Device | Other | Patients are implanted with RNS device to treat their seizure activity Receives: Device: NEUROPACE RNS SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral performance (Accuracy as fraction of correct responses)
Patients will be asked to perform a few different novel, computerized tasks where the patients must respond to on-screen stimuli using button presses. Behavior will be assessed in terms of the accuracy of these responses.
Measured: 7-14 days of behavioral performance collection
Neurophysiological activity (single-neuron activity in spikes/second)
While patients are performing each behavioral task, the investigators will measure neural activity from BlackRock using depth electrodes with the aim of isolating single-neuron activity (for patients in the EMU) and local-field potential activity (for patients in the RNS patients). Neurophysiological activity will be analyzed with the aim of understanding the neural representations underlying cognitive performance during the task.
Measured: 7-14 days of neural activity collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jun 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameer Sheth, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283811
- Sponsor's protocol ID
- H18112
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Algorithmic State Space in the Human Brain
- ClinicalTrials.gov ID
- NCT05283811
- Acronym / sponsor ID
- H18112
- Conditions
- Epilepsy
- Keywords
- Single-neuron, Local-field potentials
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Humans have a remarkable ability to flexibly interact with the environment. A compelling demonstration of this cognitive flexibility is human's ability to respond correctly to novel contextual situations on the first attempt, without prior rehearsal. The investigators refer to this ability as 'ad hoc self-programming': 'ad hoc' because these new behavioral repertoires are cobbled together on the fly, based on immediate demand, and then discarded when no longer necessary; 'self-programming' because the brain has to configure itself appropriately based on task demands and some combination of prior experience and/or instruction. The overall goal of our research effort is to understand the neurophysiological and computational basis for ad hoc self-programmed behavior. The previous U01 project (NS 108923) focused on how these programs of action are initially created. The results thus far have revealed tantalizing notions of how the brain represents these programs and navigates through the programs. In this proposal, therefore, the investigators focus on the question of how these mental programs are executed. Based on the preliminary findings and critical conceptual work, the investigators propose that the medial temporal lobe (MTL) and ventral prefrontal cortex (vPFC) creates representations of the critical elements of these mental programs, including concepts such as 'rules' and 'locations', to allow for effective navigation through the algorithm. These data suggest the existence of an 'algorithmic state space' represented in medial temporal and prefrontal regions. This proposal aims to understand the neurophysiological underpinnings of this algorithmic state space in humans. By studying humans, the investigators will profit from our species' powerful capacity for generalization to understand how such state spaces are constructed. The investigators therefore leverage the unique opportunities available in human neuroscience research to record from single cells and population-level signals, as well as to use intracranial stimulation for causal testing, to address this challenging problem. In Aim 1 the investigators study the basic representations of algorithmic state space using a novel behavioral task that requires the immediate formation of unique plans of action. Aim 2 directly compares representations of algorithmic state space to that of physical space by juxtaposing balanced versions of spatial and algorithmic tasks in a virtual reality (VR) environment. Finally, in Aim 3, the investigators test hypotheses regarding interactions between vPFC and MTL using intracranial stimulation.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy Monitoring Unit | Other | Behavioral: EMUPatient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit |
| Neuropace RNS Device | Other | Device: NEUROPACE RNS SYSTEMPatients are implanted with RNS device to treat their seizure activity |
Who may qualify
- Ages
- 10 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Eligible subjects include both male and female patients, between 10 years of age and 64 years of age, who undergo placement of intracranial electrodes for clinical characterization of epilepsy.
Key exclusion criteria (1 listed)
- Grounds for exclusion would include inability to understand and follow instructions, or inability to concentrate sufficiently to achieve a high proportion of correct responses.
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 |
|---|---|---|
| NEUROPACE RNS SYSTEMThis device is indicated as a therapy in reducing the frequency of seizures in individuals | Device | Neuropace RNS Device |
| EMUPatients are admitted to the Epilepsy Monitoring Unit for observation of seizure activity prior to further treatment | Behavioural | Epilepsy Monitoring Unit |
Primary outcome
Behavioral performance (Accuracy as fraction of correct responses)
Time frame: 7-14 days of behavioral performance collection
Patients will be asked to perform a few different novel, computerized tasks where the patients must respond to on-screen stimuli using button presses. Behavior will be assessed in terms of the accuracy of these responses.
Neurophysiological activity (single-neuron activity in spikes/second)
Time frame: 7-14 days of neural activity collection
While patients are performing each behavioral task, the investigators will measure neural activity from BlackRock using depth electrodes with the aim of isolating single-neuron activity (for patients in the EMU) and local-field potential activity (for patients in the RNS patients). Neurophysiological activity will be analyzed with the aim of understanding the neural representations underlying cognitive performance during the task.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEUROPACE RNS SYSTEM and EMU in people with Epilepsy, run by Baylor College of Medicine at 3 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sameer Sheth, MD, PhD (713-798-5060, sasheth@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral performance (Accuracy as fraction of correct responses) (time frame: 7-14 days of behavioral performance collection). 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 6 Jul 2026.