Focal EpilepsyLOOPNCT03955432
Long-term Cardiac Monitoring in Epilepsy
A study testing Reveal LINQ ICM System in people with Focal Epilepsy and Intractable Epilepsy, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this research study to investigate, classify, and quantify chronic cardiac rhythm disorders in three groups of patients with epilepsy (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Focal Epilepsy, Intractable Epilepsy, Epileptic Encephalopathy
- What is being tested?
- Reveal LINQ ICM System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2019to 3 Jan 2023
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years with ability to consent.
- No primary cardiac abnormality.
- Ability to receive an implantable loop recorder and tolerate the procedure.
- Patients with epilepsy as described by the three groups (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy)
Who cannot join
- Cardiac disease of any type
- Known epilepsy genetic disorder with potential cardiac compromise
- Major co-morbidities such as cancer, diabetes, stroke, bleeding disorder
- Chronic psychosis
- Severe MR without reliable caregiver monitoring (what is MR?)
- Already included in another clinical trial that will affect the objectives of this study.
- Life expectancy is less than 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Cardiac Monitoring in Epilepsy: Comparative Group Study to Assess Risk of Interictal and Ictal Cardiac Dysfunction
The purpose of this research study to investigate, classify, and quantify chronic cardiac rhythm disorders in three groups of patients with epilepsy (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy). Patients with epilepsy have a higher risk for cardiac complications than the general population. With this study, we aim to understand more about these potential complications in patients with epilepsy and assess if treatments for cardiac problems should be evaluated more carefully in patients with epilepsy.
Read the detailed description
Most cardiac studies have investigated patients with intractable focal epilepsy who have a high risk for co-morbidities, accidents, injury and SUDEP. This is confounded by the major antiepileptic drug burden in this population. Very little, however, is known about the risk of cardiac arrhythmias in patients with a lower seizure burden, i.e. patients with infrequent focal seizures and/or those without secondarily generalized convulsions. Furthermore, no chronic cardiac data is available in patients with epileptic encephalopathies especially given the fact that some of these patients are known to carry mutations that increase the risk for cardiac arrhythmias.In addition, periods of reduced cerebral blood flow during tachy or brady arrhythmias may exacerbate seizure severity and during. Diagnosing and treating these arrhythmias may not only prevent adverse cardiac events, but also reduce seizure burden. This study primarily aims to compare the frequency of cardiac rhythm abnormalities in patients with epilepsy of different severity, assess the long-term cardiac risk and evaluate the possible preventive role of anti-arrhythmic agents and/or cardiac pacemaker/defibrillator needs.
- Conditions
- Focal Epilepsy, Intractable Epilepsy, Epileptic Encephalopathy, Lennox Gastaut Syndrome, Symptomatic Epilepsy, Generalized Epilepsy
- Being tested
- Reveal LINQ ICM System
- Medical subject headings
- Epilepsies, Partial, Drug Resistant Epilepsy, Lennox Gastaut Syndrome, Epilepsy, Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal LINQ ICM SystemDevice
The LINQ ICM (Medtronic, Inc.) is a small FDA approved cardiac monitor implanted in the subcutaneous tissue of the chest wall that is designed to continuously record a single-lead ECG, monitoring the cardiac rhythm for up to three years. The device records and stores patient's rhythm on two occasions: first when programmed criteria are met and second upon patient activation. These programmable arrhythmia criteria are based on heart rate (bradycardia, tachycardia), irregularity of heart rate and duration of rate disturbance. The LINQ ICM (or future iterations) will be utilized in this study to detect arrhythmias in our study population.
| Study group | Role | What they receive |
|---|---|---|
| LINQ ICM | Experimental | The LINQ ICM (Medtronic, Inc.) is a small FDA approved cardiac monitor implanted in the subcutaneous tissue of the chest wall that is designed to continuously record a single-lead ECG, monitoring the cardiac rhythm for up to three years. The device records and stores patient's rhythm on two occasions: first when programmed criteria are met and second upon patient activation. These programmable arrhythmia criteria are based on heart rate (bradycardia, tachycardia), irregularity of heart rate and duration of rate disturbance. The LINQ ICM (or future iterations) will be utilized in this study to detect arrhythmias in our study population. The LINQ ICM is approved by the FDA for use in patients where there is a suspicion of occult cardiac arrhythmias and is therefore being utilized in this study in accordance with the FDA labeling. Receives: Device: Reveal LINQ ICM System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of an event (i.e., arrhythmia or seizure)
Ratio of the total number of observed events divided by the number of person-days at risk in that group. Arrhythmias will be classified into different categories based on the observed data. "Arrhythmia of any type", as well as specific categories of arrhythmias will be analyzed separately.
Measured: During the two years of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start19 Mar 2019
- Primary completion1 Nov 2022
- Study completion3 Jan 2023
Why it stopped: not enough recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Ruben Kuzniecky, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955432
- Sponsor's protocol ID
- 18-0820
- Acronym
- LOOP
- Status last verified
- Feb 2023
- First submitted
- 16 May 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Antzelevitch C, Burashnikov A. Overview of Basic Mechanisms of Cardiac Arrhythmia. Card Electrophysiol Clin. 2011 Mar 1;3(1):23-45. doi: 10.1016/j.ccep.2010.10.012. No abstract available.
PubMed 21892379Heron SE, Scheffer IE, Berkovic SF, Dibbens LM, Mulley JC. Channelopathies in idiopathic epilepsy. Neurotherapeutics. 2007 Apr;4(2):295-304. doi: 10.1016/j.nurt.2007.01.009.
PubMed 17395140Tao JX, Qian S, Baldwin M, Chen XJ, Rose S, Ebersole SH, Ebersole JS. SUDEP, suspected positional airway obstruction, and hypoventilation in postictal coma. Epilepsia. 2010 Nov;51(11):2344-7. doi: 10.1111/j.1528-1167.2010.02719.x. Epub 2010 Sep 24.
PubMed 21175606DeGiorgio CM, DeGiorgio AC. SUDEP and heart rate variability. Epilepsy Res. 2010 Aug;90(3):309-10; author reply 311-2. doi: 10.1016/j.eplepsyres.2010.03.013. Epub 2010 Apr 15. No abstract available.
PubMed 20399076So NK, Sperling MR. Ictal asystole and SUDEP. Neurology. 2007 Jul 31;69(5):423-4. doi: 10.1212/01.wnl.0000268698.04032.bc. No abstract available.
PubMed 17664399Drake ME, Reider CR, Kay A. Electrocardiography in epilepsy patients without cardiac symptoms. Seizure. 1993 Mar;2(1):63-5. doi: 10.1016/s1059-1311(05)80104-9.
PubMed 8162376Tavernor SJ, Brown SW, Tavernor RM, Gifford C. Electrocardiograph QT lengthening associated with epileptiform EEG discharges--a role in sudden unexplained death in epilepsy? Seizure. 1996 Mar;5(1):79-83. doi: 10.1016/s1059-1311(96)80067-7.
PubMed 8777558Neufeld G, Lazar JM, Chari G, Kamran H, Akajagbor E, Salciccioli L, Kassotis J, Stewart M. Cardiac repolarization indices in epilepsy patients. Cardiology. 2009;114(4):255-60. doi: 10.1159/000233236. Epub 2009 Aug 12.
PubMed 19672064Akalin F, Tirtir A, Yilmaz Y. Increased QT dispersion in epileptic children. Acta Paediatr. 2003 Aug;92(8):916-20. doi: 10.1080/08035250310003550.
PubMed 12948066Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18.
PubMed 22709423Johnson JN, Tester DJ, Bass NE, Ackerman MJ. Cardiac channel molecular autopsy for sudden unexpected death in epilepsy. J Child Neurol. 2010 Jul;25(7):916-21. doi: 10.1177/0883073809343722. Epub 2010 Apr 15.
PubMed 20395638Velagapudi P, Turagam M, Laurence T, Kocheril A. Cardiac arrhythmias and sudden unexpected death in epilepsy (SUDEP). Pacing Clin Electrophysiol. 2012 Mar;35(3):363-70. doi: 10.1111/j.1540-8159.2011.03276.x. Epub 2011 Nov 29.
PubMed 22126214Surges R, Henneberger C, Adjei P, Scott CA, Sander JW, Walker MC. Do alterations in inter-ictal heart rate variability predict sudden unexpected death in epilepsy? Epilepsy Res. 2009 Dec;87(2-3):277-80. doi: 10.1016/j.eplepsyres.2009.08.008. Epub 2009 Sep 10.
PubMed 19747799Rugg-Gunn FJ, Simister RJ, Squirrell M, Holdright DR, Duncan JS. Cardiac arrhythmias in focal epilepsy: a prospective long-term study. Lancet. 2004 Dec 18-31;364(9452):2212-9. doi: 10.1016/S0140-6736(04)17594-6.
PubMed 15610808
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Cardiac Monitoring in Epilepsy: Comparative Group Study to Assess Risk of Interictal and Ictal Cardiac Dysfunction
- ClinicalTrials.gov ID
- NCT03955432
- Acronym / sponsor ID
- LOOP / 18-0820
- Conditions
- Focal Epilepsy, Intractable Epilepsy, Epileptic Encephalopathy, Lennox Gastaut Syndrome, Symptomatic Epilepsy, Generalized Epilepsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough recruit
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 20 May 2019 (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 of this research study to investigate, classify, and quantify chronic cardiac rhythm disorders in three groups of patients with epilepsy (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy). Patients with epilepsy have a higher risk for cardiac complications than the general population. With this study, we aim to understand more about these potential complications in patients with epilepsy and assess if treatments for cardiac problems should be evaluated more carefully in patients with epilepsy.
Detailed description
Most cardiac studies have investigated patients with intractable focal epilepsy who have a high risk for co-morbidities, accidents, injury and SUDEP. This is confounded by the major antiepileptic drug burden in this population. Very little, however, is known about the risk of cardiac arrhythmias in patients with a lower seizure burden, i.e. patients with infrequent focal seizures and/or those without secondarily generalized convulsions. Furthermore, no chronic cardiac data is available in patients with epileptic encephalopathies especially given the fact that some of these patients are known to carry mutations that increase the risk for cardiac arrhythmias.In addition, periods of reduced cerebral blood flow during tachy or brady arrhythmias may exacerbate seizure severity and during. Diagnosing and treating these arrhythmias may not only prevent adverse cardiac events, but also reduce seizure burden. This study primarily aims to compare the frequency of cardiac rhythm abnormalities in patients with epilepsy of different severity, assess the long-term cardiac risk and evaluate the possible preventive role of anti-arrhythmic agents and/or cardiac pacemaker/defibrillator needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LINQ ICM | Experimental | Device: Reveal LINQ ICM SystemThe LINQ ICM (Medtronic, Inc.) is a small FDA approved cardiac monitor implanted in the subcutaneous tissue of the chest wall that is designed to continuously record a single-lead ECG, monitoring the cardiac rhythm for up to three years. The device records and stores patient's rhythm on two occasions: first when programmed criteria are met and second upon patient activation. These programmable arrhythmia criteria are based on heart rate (bradycardia, tachycardia), irregularity of heart rate and duration of rate disturbance. The LINQ ICM (or future iterations) will be utilized in this study to detect arrhythmias in our study population. The LINQ ICM is approved by the FDA for use in patients where there is a suspicion of occult cardiac arrhythmias and is therefore being utilized in this study in accordance with the FDA labeling. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-50 years with ability to consent.
- No primary cardiac abnormality.
- Ability to receive an implantable loop recorder and tolerate the procedure.
- Patients with epilepsy as described by the three groups (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy)
Key exclusion criteria (7 listed)
- Cardiac disease of any type
- Known epilepsy genetic disorder with potential cardiac compromise
- Major co-morbidities such as cancer, diabetes, stroke, bleeding disorder
- Chronic psychosis
- Severe MR without reliable caregiver monitoring (what is MR?)
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 |
|---|---|---|
| Reveal LINQ ICM SystemThe LINQ ICM (Medtronic, Inc.) is a small FDA approved cardiac monitor implanted in the subcutaneous tissue of the chest wall that is designed to continuously record a single-lead ECG, monitoring the cardiac rhythm for up to three years. The device records and stores patient's rhythm on two occasions: first when programmed criteria are met and second upon patient activation. These programmable arrhythmia criteria are based on heart rate (bradycardia, tachycardia), irregularity of heart rate and duration of rate disturbance. The LINQ ICM (or future iterations) will be utilized in this study to detect arrhythmias in our study population. | Device | LINQ ICM |
Primary outcome
Incidence rate of an event (i.e., arrhythmia or seizure)
Time frame: During the two years of monitoring
Ratio of the total number of observed events divided by the number of person-days at risk in that group. Arrhythmias will be classified into different categories based on the observed data. "Arrhythmia of any type", as well as specific categories of arrhythmias will be analyzed separately.
Results and safety
The study was stopped early (reason given: not enough recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 21892379Antzelevitch C, Burashnikov A. Overview of Basic Mechanisms of Cardiac Arrhythmia. Card Electrophysiol Clin. 2011 Mar 1;3(1):23-45. doi: 10.1016/j.ccep.2010.10.012. No abstract available.
- Background: PubMed 17395140Heron SE, Scheffer IE, Berkovic SF, Dibbens LM, Mulley JC. Channelopathies in idiopathic epilepsy. Neurotherapeutics. 2007 Apr;4(2):295-304. doi: 10.1016/j.nurt.2007.01.009.
- Background: PubMed 21175606Tao JX, Qian S, Baldwin M, Chen XJ, Rose S, Ebersole SH, Ebersole JS. SUDEP, suspected positional airway obstruction, and hypoventilation in postictal coma. Epilepsia. 2010 Nov;51(11):2344-7. doi: 10.1111/j.1528-1167.2010.02719.x. Epub 2010 Sep 24.
- Background: PubMed 20399076DeGiorgio CM, DeGiorgio AC. SUDEP and heart rate variability. Epilepsy Res. 2010 Aug;90(3):309-10; author reply 311-2. doi: 10.1016/j.eplepsyres.2010.03.013. Epub 2010 Apr 15. No abstract available.
- Background: PubMed 17664399So NK, Sperling MR. Ictal asystole and SUDEP. Neurology. 2007 Jul 31;69(5):423-4. doi: 10.1212/01.wnl.0000268698.04032.bc. No abstract available.
- Background: PubMed 8162376Drake ME, Reider CR, Kay A. Electrocardiography in epilepsy patients without cardiac symptoms. Seizure. 1993 Mar;2(1):63-5. doi: 10.1016/s1059-1311(05)80104-9.
- Background: PubMed 8777558Tavernor SJ, Brown SW, Tavernor RM, Gifford C. Electrocardiograph QT lengthening associated with epileptiform EEG discharges--a role in sudden unexplained death in epilepsy? Seizure. 1996 Mar;5(1):79-83. doi: 10.1016/s1059-1311(96)80067-7.
- Background: PubMed 19672064Neufeld G, Lazar JM, Chari G, Kamran H, Akajagbor E, Salciccioli L, Kassotis J, Stewart M. Cardiac repolarization indices in epilepsy patients. Cardiology. 2009;114(4):255-60. doi: 10.1159/000233236. Epub 2009 Aug 12.
- Background: PubMed 12948066Akalin F, Tirtir A, Yilmaz Y. Increased QT dispersion in epileptic children. Acta Paediatr. 2003 Aug;92(8):916-20. doi: 10.1080/08035250310003550.
- Background: PubMed 22709423Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18.
- Background: PubMed 20395638Johnson JN, Tester DJ, Bass NE, Ackerman MJ. Cardiac channel molecular autopsy for sudden unexpected death in epilepsy. J Child Neurol. 2010 Jul;25(7):916-21. doi: 10.1177/0883073809343722. Epub 2010 Apr 15.
- Background: PubMed 22126214Velagapudi P, Turagam M, Laurence T, Kocheril A. Cardiac arrhythmias and sudden unexpected death in epilepsy (SUDEP). Pacing Clin Electrophysiol. 2012 Mar;35(3):363-70. doi: 10.1111/j.1540-8159.2011.03276.x. Epub 2011 Nov 29.
- 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.
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?
A study testing Reveal LINQ ICM System in people with Focal Epilepsy and Intractable Epilepsy, run by Northwell Health 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 7 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 8 Feb 2023. 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?
The study was stopped early (reason given: not enough recruit). 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?
Incidence rate of an event (i.e., arrhythmia or seizure) (time frame: During the two years of monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03955432, which also lists 14 linked publications.
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 Feb 2023.