EpilepsyNCT05520476
Neuroliten MVP System Clinical Observation Study
An observational study of Epilepsy, run by Enliten AI at 1 site in United States.
Trial summary
This is an observational study for data collection from subjects diagnosed with Epilepsy/intractable seizures. The Neuroliten MVP System will not be used for patient management or treatment decisions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Neuroliten MVP system
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a documented history of at least 2 seizures per week.
Who may be able to join
- An Institutional Review Board (IRB) approved informed consent is signed and dated before any study-related activities.
- Male and female subjects ages 18 to 75, inclusive.
- Documented history of at least two (2) seizures per week. Seizures can be generalized and/or focal.
- Diagnosed with intractable or refractory epilepsy.
- Have a caregiver/family member who stays with the subject, has the ability to detect seizures, and is willing to provide the information needed for the study.
- Have implanted vagus nerve stimulation (VNS).
- Have the ability to understand the requirements of the study and are willing to comply with all study requirements.
- Must have a working Apple iPhone.
Who cannot join
- Women who are either pregnant or breastfeeding.
- Subjects unable/unwilling to wear the Apple Watch and EEG Wearable for extended periods.
- Requires the use of a ventilator.
- Requires the use of supplemental oxygen.
- Uses a pacemaker or other electronic neurostimulator, except the VNS.
- Any medical or surgical condition that in the opinion of the investigator may interfere with participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study for data collection from subjects diagnosed with Epilepsy/intractable seizures. The Neuroliten MVP System will not be used for patient management or treatment decisions.
Read the detailed description
Neuroliten MVP system stores the data obtained from wearables, caregivers, and all audio/video recording of seizure activity that the caregiver captures associated with a seizure episode.
The primary objective of this study is to obtain vital signs and neurological indicators via the Neuroliten MVP System to correlate to the onset of seizures that are detected by the observations of family/caregivers.
The secondary objective is to identify the vital signs and/or neurological indicators that are associated with seizure onset.
- Conditions
- Epilepsy
- Being tested
- Neuroliten MVP system
- Keywords
- Seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroliten MVP systemDevice
The Neuroliten MVP system will be an App that gets uploaded to the patients iPhone from the App Store.
| Study group | Role | What they receive |
|---|---|---|
| 20 patients with at least two seizures per week. | The device collects vital signs and EEG data as well as caregiver information associated with seizure episodes. Receives: Device: Neuroliten MVP system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart Rate (beats per minute)
Measured: 90 days
Oxygen Saturation
Oxygen Saturation (SpO2 %)
Measured: 90 days
Respiratory Rate
Respiratory Rate (breaths per minute)
Measured: 90 days
Blood Pressure
Blood Pressure (mmHg)
Measured: 90 days
Temperature
Temperature (Fahrenheit)
Measured: 90 days
Brain Signals
Brain signals obtained using a 14-channel EEG Wearable
Measured: 90 Days
Secondary outcomes (1)
Clinical Observations from Caregiver
Caregiver will log details of specific seizure episodes with the following measures:
- Date, Time and Duration of Seizure
- Type of seizure (if known)
- Caregiver's assessment of severity (1-10, 10 being very severe)
- Cluster of seizures (How many were observed and interval)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start31 Oct 2022
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enliten AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSSi Life Sciences
- Responsible party
- Sponsor
- Investigators
- Barbara Hager, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520476
- Sponsor's protocol ID
- EL-001
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroliten MVP System Clinical Observation Study
- ClinicalTrials.gov ID
- NCT05520476
- Acronym / sponsor ID
- EL-001
- Conditions
- Epilepsy
- Keywords
- Seizures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Enliten AIIndustry (pharma, biotech, devices)
- Collaborators
- CSSi Life Sciences
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Aug 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.
This is an observational study for data collection from subjects diagnosed with Epilepsy/intractable seizures. The Neuroliten MVP System will not be used for patient management or treatment decisions.
Detailed description
Neuroliten MVP system stores the data obtained from wearables, caregivers, and all audio/video recording of seizure activity that the caregiver captures associated with a seizure episode.
The primary objective of this study is to obtain vital signs and neurological indicators via the Neuroliten MVP System to correlate to the onset of seizures that are detected by the observations of family/caregivers.
The secondary objective is to identify the vital signs and/or neurological indicators that are associated with seizure onset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 patients with at least two seizures per week. | – | Device: Neuroliten MVP systemThe device collects vital signs and EEG data as well as caregiver information associated with seizure episodes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a documented history of at least 2 seizures per week.
Key inclusion criteria (8 listed)
- An Institutional Review Board (IRB) approved informed consent is signed and dated before any study-related activities.
- Male and female subjects ages 18 to 75, inclusive.
- Documented history of at least two (2) seizures per week. Seizures can be generalized and/or focal.
- Diagnosed with intractable or refractory epilepsy.
- Have a caregiver/family member who stays with the subject, has the ability to detect seizures, and is willing to provide the information needed for the study.
Key exclusion criteria (6 listed)
- Women who are either pregnant or breastfeeding.
- Subjects unable/unwilling to wear the Apple Watch and EEG Wearable for extended periods.
- Requires the use of a ventilator.
- Requires the use of supplemental oxygen.
- Uses a pacemaker or other electronic neurostimulator, except the VNS.
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 |
|---|---|---|
| Neuroliten MVP systemThe Neuroliten MVP system will be an App that gets uploaded to the patients iPhone from the App Store. | Device | 20 patients with at least two seizures per week. |
Primary outcome
Heart Rate
Time frame: 90 days
Heart Rate (beats per minute)
Oxygen Saturation
Time frame: 90 days
Oxygen Saturation (SpO2 %)
Respiratory Rate
Time frame: 90 days
Respiratory Rate (breaths per minute)
Blood Pressure
Time frame: 90 days
Blood Pressure (mmHg)
Temperature
Time frame: 90 days
Temperature (Fahrenheit)
Brain Signals
Time frame: 90 Days
Brain signals obtained using a 14-channel EEG Wearable
1 secondary outcome
Clinical Observations from Caregiver
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- 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. This study is not recruiting at the moment.
Barbara Hager, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Enliten AI 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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?
Results are not available in the source record.
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?
Heart Rate (time frame: 90 days). The study lists 6 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 27 Aug 2024.