EpilepsyNCT03038191
Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home
An observational study of Epilepsy, run by Medial Research Ltd. at 1 site in Israel.
Trial summary
Epilepsy is a group of neurological disorders characterized by propensity for spontaneous epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell activity in the brain. About 0.7-1% of the world population suffers from seizures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Neuroelectrics Enobio 8(R)
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Mar 2017to 30 Jun 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult epilepsy patients who are admitted to the video EEG unit and are expected to experience seizures during hospitalization
Who may be able to join
- Age >18
- Known diagnosis of Epilepsy
- Expected to experience seizures during the period of the study as determined by the PI.
- Able to meet with the Sponsor representative at home
Who cannot join
- Trauma/broken skin on forehead.
- Patient can not follow or comply with instructions
- Patients who are unable to independently provide an informed consent
- Patients with major psychiatric co-morbidities
- Patients with psychogenic non-epileptic seizures
Trial locations and contacts
1 site in 1 country.
About this study
Epilepsy is a group of neurological disorders characterized by propensity for spontaneous epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell activity in the brain. About 0.7-1% of the world population suffers from seizures. The most common treatment is based on seizure medications that enables about 2/3 of the patients to control their seizures. However, about 20 million patients worldwide, suffer from unpredictable seizures without remedy, and are resistant to medication.
In this study EEG and other physiologic signals are collected using wearable sensors, from Epilepsy patients who are at risk of experiencing seizures. The collected signals will be used for developing algorithms that may identify pre-seizure and seizure related periods.
- Conditions
- Epilepsy
- Being tested
- Neuroelectrics Enobio 8(R)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroelectrics Enobio 8(R)Device
Monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful data collection during hospitalization
Continuous recording from wearable sensors of physiologic signals during hospitalization in the video EEG unit
Measured: 12 hours daily for up to 5 days
Successful data collection during at home monitoring
Continuous recording from wearable sensors of physiologic signals during at home monitoring
Measured: 12 hours daily for up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start8 Mar 2017
- Primary completion30 Dec 2018
- Study completion30 Jun 2019
Why it stopped: Sponsor stopped funding
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
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medial Research Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Firas Fahoum, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038191
- Sponsor's protocol ID
- CA-EPIPRO-TASMC-HOSP-02
- Status last verified
- Sep 2021
- First submitted
- 12 Jan 2017
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epi-collect: Data Collection During Video EEG Monitoring and at Patient's Home
- ClinicalTrials.gov ID
- NCT03038191
- Acronym / sponsor ID
- CA-EPIPRO-TASMC-HOSP-02
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor stopped funding
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Medial Research Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 31 Jan 2017 (estimated)
- 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.
Epilepsy is a group of neurological disorders characterized by propensity for spontaneous epileptic seizures. Epileptic seizures are the result of excessive and abnormal nerve cell activity in the brain. About 0.7-1% of the world population suffers from seizures. The most common treatment is based on seizure medications that enables about 2/3 of the patients to control their seizures. However, about 20 million patients worldwide, suffer from unpredictable seizures without remedy, and are resistant to medication.
In this study EEG and other physiologic signals are collected using wearable sensors, from Epilepsy patients who are at risk of experiencing seizures. The collected signals will be used for developing algorithms that may identify pre-seizure and seizure related periods.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult epilepsy patients who are admitted to the video EEG unit and are expected to experience seizures during hospitalization
Key inclusion criteria (4 listed)
- Age >18
- Known diagnosis of Epilepsy
- Expected to experience seizures during the period of the study as determined by the PI.
- Able to meet with the Sponsor representative at home
Key exclusion criteria (5 listed)
- Trauma/broken skin on forehead.
- Patient can not follow or comply with instructions
- Patients who are unable to independently provide an informed consent
- Patients with major psychiatric co-morbidities
- Patients with psychogenic non-epileptic seizures
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 |
|---|---|---|
| Neuroelectrics Enobio 8(R)Monitoring | Device | – |
Primary outcome
Successful data collection during hospitalization
Time frame: 12 hours daily for up to 5 days
Continuous recording from wearable sensors of physiologic signals during hospitalization in the video EEG unit
Successful data collection during at home monitoring
Time frame: 12 hours daily for up to 14 days
Continuous recording from wearable sensors of physiologic signals during at home monitoring
Results and safety
The study was stopped early (reason given: Sponsor stopped funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Medial Research Ltd. at 1 site in Israel.
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 5 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: stopped early, as of the sponsor's last update on 13 Sep 2021. 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 Israel. 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?
The study was stopped early (reason given: Sponsor stopped funding). 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?
Successful data collection during hospitalization (time frame: 12 hours daily for up to 5 days). 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 13 Sep 2021.