EpilepsyCAPTURENCT06883981
Capturing Autobiographical Memory Formation in Real World Spaces Using Multimodal Recordings
A study testing Free and Cued Recall Memory. Temporal Sequence and Spatial Memory in people with Epilepsy and Autobiographical Memory, run by University of Utah at 1 site in United States.
Trial summary
The goal of this observational study is to develop novel methods for integrating multimodal data streams with invasive neural recordings to study autobiographical memory (AM) formation in individuals with implanted neurostimulation devices (e.g., NeuroPace RNS) for epilepsy treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Autobiographical Memory
- What is being tested?
- Free and Cued Recall Memory. Temporal Sequence and Spatial Memory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- healthy to minor cognitive impairment
Who cannot join
- younger than 18 years of age
- more than minor cognitive impairment
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, 1 recruiting
- Recruiting
Clinical Neurosciences Center, University of Utah
Salt Lake City, Utah, 84132
Cory S Inman, PhD, 801-581-8939, inmanneurolab@gmail.com
About this study
Official title: Capturing Autobiographical Memory Formation in People Moving Through Real-World Spaces Using Synchronized Wearables and Intracranial Recordings of EEG
The goal of this observational study is to develop novel methods for integrating multimodal data streams with invasive neural recordings to study autobiographical memory (AM) formation in individuals with implanted neurostimulation devices (e.g., NeuroPace RNS) for epilepsy treatment. The main questions it aims to answer are:
How does the brain encode and retrieve real-world autobiographical memories? Can multimodal data integration enhance our understanding of memory-related cognitive and neural mechanisms?
Read more
Participants will:
- Use a smartphone-based recording application (CAPTURE app) to collect real-world data.
- Have their wearable sensor data (e.g., audio-visual, accelerometry, GPS, autonomic physiology, eye tracking) synchronized with invasive neural recordings.
Researchers will analyze these multimodal data streams to develop new analytic approaches for studying memory formation in naturalistic settings, with the long-term goal of informing neuromodulation-based memory enhancement treatments for individuals with memory disorders.
Read the detailed description
This observational study aims to develop and validate novel methodologies for integrating multimodal data streams with invasive neural recordings in individuals with implanted neurostimulation devices (e.g., NeuroPace RNS) undergoing treatment for epilepsy. The study focuses on understanding the neural mechanisms underlying autobiographical memory (AM) formation and retrieval in real-world settings. By leveraging real-time, ecologically valid data collection, this research seeks to bridge the gap between controlled laboratory-based memory studies and naturalistic memory processes.
Study Design and Data Collection Participants with implanted neurostimulation devices will use a smartphone-based application (CAPTURE) to log real-world experiences while wearing additional sensors to record behavioral, physiological, and environmental data.
The study integrates multiple data modalities, including:
- Neural recordings from implanted neurostimulation devices
- Wearable sensor data, including:
- Audio-visual recordings
- GPS location tracking
- Accelerometry for movement analysis
- Autonomic physiology measurements (e.g., heart rate, skin conductance)
- Eye-tracking data
By synchronizing these data streams, researchers will establish a high-fidelity representation of autobiographical memory encoding and retrieval processes in daily life.
Analytic Methods and Data Integration
This study aims to develop computational frameworks for real-time data alignment and analysis. The primary methodological goals include:
- Temporal synchronization of multimodal data with neural recordings
- Automated feature extraction from behavioral and physiological data
- Neural signal processing techniques to identify patterns of activity associated with memory formation and retrieval
- Development of machine learning models to predict successful memory encoding and recall based on neural and behavioral signals
- These analytic advancements will enable researchers to assess memory-related brain activity in naturalistic environments, providing insights into the neural correlates of real-world autobiographical memory.
Potential Impact:
The findings from this study have significant implications for neuroscience, cognitive psychology, and clinical applications. By establishing methods for naturalistic neural recording and analysis, this research paves the way for neuromodulation-based memory enhancement therapies for individuals with memory disorders, including those with epilepsy, traumatic brain injury, and neurodegenerative diseases. The study also advances real-world cognitive neuroscience, enabling a deeper understanding of how the brain supports memory outside of laboratory settings.
- Conditions
- Epilepsy, Autobiographical Memory
- Being tested
- Free and Cued Recall Memory. Temporal Sequence and Spatial Memory
- Keywords
- Autobiographical memory, Memory, IEEG, Epilepsy, Real-World Navigation, Spatial Memory, Hippocampus, Medial Temporal Cortex, Multi-Modal Recording
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free and Cued Recall Memory. Temporal Sequence and Spatial MemoryBehavioural
Memory for real-world episodic experiences will be tested in the laboratory first with free recall (spoken narration of their recollections from each environment) and then with cued recall, in which participants will be cued with an event image from the CAPTURE app, a map location, or a relative time and asked to recall the other two non-cued pieces of episodic information (event, place, or time). Because we will know the 'ground truth', the cued recall test will allow us to measure how accurately the participant is able to remember key details of each episode. We will also assess temporal order memory by asking participants to arrange 1st person images in the order in which they occurred, and we will assess spatial memory by asking them to place each image on a schematic map of the venue.
| Study group | Role | What they receive |
|---|---|---|
| Neuroethical Assessment Group | No intervention | Patients with epilepsy who have Neuropace RNS implants who will be surveyed about the neuroethics of real-world multi-modal recordings to assess their attitude toward research data sharing and confidentiality. |
| Multi-Modal Recording System Assessment Group | Experimental | Patients with epilepsy who have Neuropace RNS implants, and patients without epilepsy/RNS implants, who will participate in real-world navigation and autobiographical memory tasks in order to evaluate the reliability and signal quality of the multi-modal recording system. Receives: Behavioral: Free and Cued Recall Memory. Temporal Sequence and Spatial Memory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial EEG power in Theta Band
iEEG power in the theta band between 4-8 Hz, will be assessed to identify the real-world experience features that contribute to changes in this important neural power band for memory encoding.
Measured: 4 days
Intracranial EEG power in Gamma Band
iEEG power in the gamma band between 30-100 Hz, will be assessed to identify the real-world experience features that contribute to changes in this important neural power band for memory encoding.
Measured: 4 days
Intracranial EEG normalized aperiodic exponent
This feature of intracranial EEG will be assessed as a broadband state-level change in brain activity during the participant's real-world experiences.
Measured: 4 days
Secondary outcomes (1)
Eye fixation duration to remembered experiences
Using eye-tracking, we will use the duration in time participants fixate on remembered experiences as a measure of visual attention.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start30 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 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.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH), University of California, San Diego, University of California, Los Angeles
- Responsible party
- Principal investigator, Cory Inman, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883981
- Sponsor's protocol ID
- 00183967
- Other IDs
- 1R61MH135109-01
- Acronym
- CAPTURE
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capturing Autobiographical Memory Formation in People Moving Through Real-World Spaces Using Synchronized Wearables and Intracranial Recordings of EEG
- ClinicalTrials.gov ID
- NCT06883981
- Acronym / sponsor ID
- CAPTURE / 00183967
- Conditions
- Epilepsy, Autobiographical Memory
- Keywords
- Autobiographical memory, Memory, IEEG, Epilepsy, Real-World Navigation, Spatial Memory, Hippocampus, Medial Temporal Cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH), University of California, San Diego, University of California, Los Angeles
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Mar 2025 (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 goal of this observational study is to develop novel methods for integrating multimodal data streams with invasive neural recordings to study autobiographical memory (AM) formation in individuals with implanted neurostimulation devices (e.g., NeuroPace RNS) for epilepsy treatment. The main questions it aims to answer are:
How does the brain encode and retrieve real-world autobiographical memories? Can multimodal data integration enhance our understanding of memory-related cognitive and neural mechanisms?
Participants will:
- Use a smartphone-based recording application (CAPTURE app) to collect real-world data.
- Have their wearable sensor data (e.g., audio-visual, accelerometry, GPS, autonomic physiology, eye tracking) synchronized with invasive neural recordings.
Researchers will analyze these multimodal data streams to develop new analytic approaches for studying memory formation in naturalistic settings, with the long-term goal of informing neuromodulation-based memory enhancement treatments for individuals with memory disorders.
Detailed description
This observational study aims to develop and validate novel methodologies for integrating multimodal data streams with invasive neural recordings in individuals with implanted neurostimulation devices (e.g., NeuroPace RNS) undergoing treatment for epilepsy. The study focuses on understanding the neural mechanisms underlying autobiographical memory (AM) formation and retrieval in real-world settings. By leveraging real-time, ecologically valid data collection, this research seeks to bridge the gap between controlled laboratory-based memory studies and naturalistic memory processes.
Study Design and Data Collection Participants with implanted neurostimulation devices will use a smartphone-based application (CAPTURE) to log real-world experiences while wearing additional sensors to record behavioral, physiological, and environmental data.
The study integrates multiple data modalities, including:
- Neural recordings from implanted neurostimulation devices
- Wearable sensor data, including:
- Audio-visual recordings
- GPS location tracking
- Accelerometry for movement analysis
- Autonomic physiology measurements (e.g., heart rate, skin conductance)
- Eye-tracking data
By synchronizing these data streams, researchers will establish a high-fidelity representation of autobiographical memory encoding and retrieval processes in daily life.
Analytic Methods and Data Integration
This study aims to develop computational frameworks for real-time data alignment and analysis. The primary methodological goals include:
- Temporal synchronization of multimodal data with neural recordings
- Automated feature extraction from behavioral and physiological data
- Neural signal processing techniques to identify patterns of activity associated with memory formation and retrieval
- Development of machine learning models to predict successful memory encoding and recall based on neural and behavioral signals
- These analytic advancements will enable researchers to assess memory-related brain activity in naturalistic environments, providing insights into the neural correlates of real-world autobiographical memory.
Potential Impact:
The findings from this study have significant implications for neuroscience, cognitive psychology, and clinical applications. By establishing methods for naturalistic neural recording and analysis, this research paves the way for neuromodulation-based memory enhancement therapies for individuals with memory disorders, including those with epilepsy, traumatic brain injury, and neurodegenerative diseases. The study also advances real-world cognitive neuroscience, enabling a deeper understanding of how the brain supports memory outside of laboratory settings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuroethical Assessment Group | No intervention | –Patients with epilepsy who have Neuropace RNS implants who will be surveyed about the neuroethics of real-world multi-modal recordings to assess their attitude toward research data sharing and confidentiality. |
| Multi-Modal Recording System Assessment Group | Experimental | Behavioral: Free and Cued Recall Memory. Temporal Sequence and Spatial MemoryPatients with epilepsy who have Neuropace RNS implants, and patients without epilepsy/RNS implants, who will participate in real-world navigation and autobiographical memory tasks in order to evaluate the reliability and signal quality of the multi-modal recording system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- healthy to minor cognitive impairment
Key exclusion criteria (2 listed)
- younger than 18 years of age
- more than minor cognitive impairment
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 |
|---|---|---|
| Free and Cued Recall Memory. Temporal Sequence and Spatial MemoryMemory for real-world episodic experiences will be tested in the laboratory first with free recall (spoken narration of their recollections from each environment) and then with cued recall, in which participants will be cued with an event image from the CAPTURE app, a map location, or a relative time and asked to recall the other two non-cued pieces of episodic information (event, place, or time). Because we will know the 'ground truth', the cued recall test will allow us to measure how accurately the participant is able to remember key details of each episode. We will also assess temporal order memory by asking participants to arrange 1st person images in the order in which they occurred, and we will assess spatial memory by asking them to place each image on a schematic map of the venue. | Behavioural | Multi-Modal Recording System Assessment Group |
Primary outcome
Intracranial EEG power in Theta Band
Time frame: 4 days
iEEG power in the theta band between 4-8 Hz, will be assessed to identify the real-world experience features that contribute to changes in this important neural power band for memory encoding.
Intracranial EEG power in Gamma Band
Time frame: 4 days
iEEG power in the gamma band between 30-100 Hz, will be assessed to identify the real-world experience features that contribute to changes in this important neural power band for memory encoding.
Intracranial EEG normalized aperiodic exponent
Time frame: 4 days
This feature of intracranial EEG will be assessed as a broadband state-level change in brain activity during the participant's real-world experiences.
1 secondary outcome
Eye fixation duration to remembered experiences
Time frame: 4 days
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 8 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free and Cued Recall Memory. Temporal Sequence and Spatial Memory in people with Epilepsy and Autobiographical Memory, run by University of Utah 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 2 inclusion and 2 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 8 Apr 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?
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 Alireza Kazemi, PhD (5303040970, alireza.kazemi@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial EEG power in Theta Band (time frame: 4 days). The study lists 3 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 8 Apr 2025.