Epilepsy IntractableNCT04500119
Neuronal Mechanisms of Human Episodic Memory
A study testing Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulator in people with Epilepsy Intractable, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, recalling stored information, and making decisions or choices about presented information. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Epilepsy Intractable
- What is being tested?
- Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 31 Jul 2027
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Intractable epilepsy, undergoing invasive monitoring
- Age ≥13
- Full Scale Intelligence Quotient > 70
- Ability to comprehend and perform simple behavioral tasks by pressing buttons on laptop computer in response to questions.
Who cannot join
- Determination by clinicians and investigators that a patient is unable to complete the behavioral tasks required for the protocol due to either cognitive limits, psychological limits, or pain.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
The purpose the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, recalling stored information, and making decisions or choices about presented information. These investigations are critical to better understand human cognition and to design treatments for disorders of learning and memory.
Read the detailed description
The rapid formation of new memories and the recall of old memories to inform decisions is essential for human cognition, but the underlying neural mechanisms remain poorly understood. The long-term goal of this research is a circuit-level understanding of human memory to enable the development of new treatments for the devastating effects of memory disorders. The study experiments utilize the rare opportunity to record in-vivo from human single neurons simultaneously in multiple brain areas in patients undergoing treatment for drug resistant epilepsy. The overall objective is to continue and expand a multi-institutional (Cedars Sinai/Caltech, Johns Hopkins, U Toronto, Children's/Harvard, UC Denver, UCSB), integrated, and multi-disciplinary team. Jointly, the investigators have the expertise and patient volume to test key predictions on the neural substrate of human memory. The study will utilize a combination of (i) in-vivo recordings in awake behaving humans assessing memory strength through confidence ratings, (ii) focal electrical stimulation to test causality, and (iii) computational analysis and modeling.
These techniques will be applied to investigate three overarching hypotheses on the mechanisms of episodic memory. First, to determine the role of persistent neuronal activity in translating working memories into longterm declarative memories (Aim 1). Second, to determine how declarative memories are translated into decisions (Aim 2). Third, to investigate how event segmentation, temporal binding and reinstatement during temporally extended experience facilitate episodic memory.
The expected outcomes of this work are an unprecedented characterization of how episodic memories are formed, retrieved and used for decisions, and how temporally extended experiences are segmented to form distinct but linked episodes. This work is significant because it moves beyond a "parts list" of neurons and brain areas by testing circuit-based hypotheses by simultaneously recording single-neurons from multiple frontal cortical and subcortical temporal lobe areas in humans who are forming, declaring and describing their memories. The proposed work is unusually innovative because it combines single-neuron recordings in multiple areas in behaving humans, develops new methods for non-invasive localization of implanted electrodes and electrical stimulation and directly test long-standing theoretical predictions on the role of evidence accumulation in memory retrieval.
A second significant innovation is the study team, which combines the patient volume and expertise of several major centers to maximally utilize the rare neurosurgical opportunities available to directly study the human nervous system. This innovative approach permits investigation of circuit-level mechanisms of human memory that cannot be studied non-invasively in humans nor in animal models. This integrated multi-disciplinary combination of human in-vivo single-neuron physiology, behavior, and modeling will contribute significantly to the understanding of the circuits and patterns of neural activity that give rise to human memory, which is a central goal of human neuroscience in general and the BRAIN initiative in particular.
- Conditions
- Epilepsy Intractable
- Being tested
- Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulator
- Keywords
- Epilepsy, Decision-making, Memory, Depth Electrode
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulatorBehavioural
Devices listed are components of a single intervention that includes: Record patient responses (Cedrus RB-844), record neuronal activity (Neurolynx) from electrodes (Adtech Behnke-Fried), apply intermittent electrical stimulation (Blackrock Cerestim)
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Testing | Experimental | Behavioral and Neuronal Recordings Receives: Behavioral: Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Neuronal Activity (Firing Rates)
Neuronal firing rates (measured in spike rates per second) of cells in the frontal and temporal lobes during working memory.
Measured: 3 years
Persistent Neuronal Activity (Power)
Power of local field potential bandwidths (measured in amplitude across frequency of the bandwidths) in the frontal and temporal lobes during working memory.
Measured: 3 years
Decision Making (Firing Rates)
Neuronal firing rates of cells (measured in spike rates per second) in the frontal and temporal lobes during a decision-making process.
Measured: 5 years
Decision Making (Power)
Power of local field potential bandwidths (measured in amplitude across frequency of the bandwidths) in the frontal and temporal lobes during a decision-making process.
Measured: 5 years
Decision Making (Timing)
Timing of neuronal discharges (measured in spike rates per second) across the frontal and temporal lobes during a decision-making process.
Measured: 5 years
Disruption of learning and memory via electrical stimulation (firing rates)
Measure the change in firing rates of neurons (measured in amplitude across frequency of the bandwidths) after applying small pulse of electrical activity during a learning task.
Measured: 5 years
Disruption of learning and memory via electrical stimulation (memory)
Measure the change in memory (measured in spike rates per second) observed after applying small pulse of electrical activity during a learning task.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start12 Aug 2020
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy IntractableStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Colorado, Denver, University Health Network, Toronto, Boston Children's Hospital, University of California, Santa Barbara, National Institute of Neurological Disorders and Stroke (NINDS), California Institute of Technology
- Responsible party
- Principal investigator, Adam Mamelak, MD, Cedars-Sinai Medical Center
- Investigators
- Ueli Rutishauser, PhD, Principal investigator, Cedars-Sinai Medical CenterAdam Mamelak, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500119
- Sponsor's protocol ID
- STUDY00000572
- Other IDs
- 5U01NS117839-03
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Mechanisms of Human Episodic Memory
- ClinicalTrials.gov ID
- NCT04500119
- Acronym / sponsor ID
- STUDY00000572
- Conditions
- Epilepsy Intractable
- Keywords
- Epilepsy, Decision-making, Memory, Depth Electrode
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of Colorado, Denver, University Health Network, Toronto, Boston Children's Hospital, University of California, Santa Barbara, National Institute of Neurological Disorders and Stroke (NINDS), California Institute of Technology
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 Aug 2020 (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.
The purpose the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, recalling stored information, and making decisions or choices about presented information. These investigations are critical to better understand human cognition and to design treatments for disorders of learning and memory.
Detailed description
The rapid formation of new memories and the recall of old memories to inform decisions is essential for human cognition, but the underlying neural mechanisms remain poorly understood. The long-term goal of this research is a circuit-level understanding of human memory to enable the development of new treatments for the devastating effects of memory disorders. The study experiments utilize the rare opportunity to record in-vivo from human single neurons simultaneously in multiple brain areas in patients undergoing treatment for drug resistant epilepsy. The overall objective is to continue and expand a multi-institutional (Cedars Sinai/Caltech, Johns Hopkins, U Toronto, Children's/Harvard, UC Denver, UCSB), integrated, and multi-disciplinary team. Jointly, the investigators have the expertise and patient volume to test key predictions on the neural substrate of human memory. The study will utilize a combination of (i) in-vivo recordings in awake behaving humans assessing memory strength through confidence ratings, (ii) focal electrical stimulation to test causality, and (iii) computational analysis and modeling.
These techniques will be applied to investigate three overarching hypotheses on the mechanisms of episodic memory. First, to determine the role of persistent neuronal activity in translating working memories into longterm declarative memories (Aim 1). Second, to determine how declarative memories are translated into decisions (Aim 2). Third, to investigate how event segmentation, temporal binding and reinstatement during temporally extended experience facilitate episodic memory.
The expected outcomes of this work are an unprecedented characterization of how episodic memories are formed, retrieved and used for decisions, and how temporally extended experiences are segmented to form distinct but linked episodes. This work is significant because it moves beyond a "parts list" of neurons and brain areas by testing circuit-based hypotheses by simultaneously recording single-neurons from multiple frontal cortical and subcortical temporal lobe areas in humans who are forming, declaring and describing their memories. The proposed work is unusually innovative because it combines single-neuron recordings in multiple areas in behaving humans, develops new methods for non-invasive localization of implanted electrodes and electrical stimulation and directly test long-standing theoretical predictions on the role of evidence accumulation in memory retrieval.
A second significant innovation is the study team, which combines the patient volume and expertise of several major centers to maximally utilize the rare neurosurgical opportunities available to directly study the human nervous system. This innovative approach permits investigation of circuit-level mechanisms of human memory that cannot be studied non-invasively in humans nor in animal models. This integrated multi-disciplinary combination of human in-vivo single-neuron physiology, behavior, and modeling will contribute significantly to the understanding of the circuits and patterns of neural activity that give rise to human memory, which is a central goal of human neuroscience in general and the BRAIN initiative in particular.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Testing | Experimental | Behavioral: Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulatorBehavioral and Neuronal Recordings |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Intractable epilepsy, undergoing invasive monitoring
- Age ≥13
- Full Scale Intelligence Quotient > 70
- Ability to comprehend and perform simple behavioral tasks by pressing buttons on laptop computer in response to questions.
Key exclusion criteria (1 listed)
- Determination by clinicians and investigators that a patient is unable to complete the behavioral tasks required for the protocol due to either cognitive limits, psychological limits, or pain.
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 |
|---|---|---|
| Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulatorDevices listed are components of a single intervention that includes: Record patient responses (Cedrus RB-844), record neuronal activity (Neurolynx) from electrodes (Adtech Behnke-Fried), apply intermittent electrical stimulation (Blackrock Cerestim) | Behavioural | Behavioral Testing |
Primary outcome
Persistent Neuronal Activity (Firing Rates)
Time frame: 3 years
Neuronal firing rates (measured in spike rates per second) of cells in the frontal and temporal lobes during working memory.
Persistent Neuronal Activity (Power)
Time frame: 3 years
Power of local field potential bandwidths (measured in amplitude across frequency of the bandwidths) in the frontal and temporal lobes during working memory.
Decision Making (Firing Rates)
Time frame: 5 years
Neuronal firing rates of cells (measured in spike rates per second) in the frontal and temporal lobes during a decision-making process.
Decision Making (Power)
Time frame: 5 years
Power of local field potential bandwidths (measured in amplitude across frequency of the bandwidths) in the frontal and temporal lobes during a decision-making process.
Decision Making (Timing)
Time frame: 5 years
Timing of neuronal discharges (measured in spike rates per second) across the frontal and temporal lobes during a decision-making process.
Disruption of learning and memory via electrical stimulation (firing rates)
Time frame: 5 years
Measure the change in firing rates of neurons (measured in amplitude across frequency of the bandwidths) after applying small pulse of electrical activity during a learning task.
Disruption of learning and memory via electrical stimulation (memory)
Time frame: 5 years
Measure the change in memory (measured in spike rates per second) observed after applying small pulse of electrical activity during a learning 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 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Ueli Rutishauser, PhD principal investigator
Cedars-Sinai Medical Center
Adam Mamelak, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulator in people with Epilepsy Intractable, run by Cedars-Sinai Medical Center 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 4 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. 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?
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?
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?
Persistent Neuronal Activity (Firing Rates) (time frame: 3 years). The study lists 7 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 17 Sep 2026.