EpilepsyERASNCT04095247
Does Pulse-triggered VNS Autostimulation Increase VNS Efficacy
An observational study of Epilepsy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This is a research study to investigate whether the use of an extra function of vagus nerve stimulator (VNS) can give an improved effect against epilepsy. Many epileptic seizures are accompanied by an increase in heart rate. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Vagus nerv stimulator
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteNorway
- Study dates
- 3 Apr 2018to 6 Apr 2022
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Eligible for the study are subjects (males and females) 12 years of age or older who had been using a VNS for at least three years with a positive effect and are getting a device replacement due to low battery capacity or who had a replacement and had not started the additional ECG -triggered stimulation before the study.
Who may be able to join
- Subjects, 12 years of age or older, who have a VNS without ECG-triggered auto stimulation implanted, have a positive effect and have a device replacement with model 106 or model 1000 due to low battery capacity,.
- Subjects, who have 2 or more seizure per month and not more than 28 days between seizures during the baseline.
- Subjects, who are on a stable regiment of antiepileptic drug treatment for at least 3 month prior to enrollment and maintain on this regimen throughout the study.
- VNS parameters have not been changed I the last 3 month prior to enrollment.
- Subjects which are using an off time of at least 1.8 min. (If the patient is on a duty cycle involving an off-time of 1.1 min. or less, and willing to participate in the study the duty cycle will have to be changed to fulfill the inclusion criteria as follows. The off-time will be changed to 1.8 min. and the on-time accordingly to achieve about the same duty cycle as the patient had before. If the duty cycle is above 30% the parameters will be changed to 60 sec./1.8 min., if the duty cycle is between 30% and 23% the parameters will be change to 30 sec./1,8 min., if the duty cycle is 20% the parameters will be change to 21 sec./1,8 min. and if the duty cycle is 15% the parameters will be change to 14 sec./1,8 min. After at periode of 3 month observation the patient can be included in the study.)
- Either the subjects or the legal guardian are able to agree to participate by signing the informed consent form.
Who cannot join
- Subjects with rapidly progressive neurodegenerative or rapidly progressing neoplastic disease.
- Subjects or legal guardians who are unable to understand the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Additional ECG-triggered Stimulation Increase the Efficacy of Vagus Nerve Stimulation? An Investigator-initiated Prospective, Multinational, Single Blinded, Randomized Cross-over Trial in Patients With VNS-treatment
This is a research study to investigate whether the use of an extra function of vagus nerve stimulator (VNS) can give an improved effect against epilepsy. Many epileptic seizures are accompanied by an increase in heart rate. One auxiliary function of a new type of stimulator is continuous measurement of cardiac activity, and when pulse rate increases an extra stimulation is delivered. It has been shown that this can interrupt attacks that are about to develop. In this project the investigators will test how well that works for patients in daily life. The new type of stimulator has similar design and location as the old one. Patients who have already been treated with VNS and who need to switch the stimulator because the battery is starting to run out, are asked whether they want to participate. The study is a randomized and blinded cross-over. The activation of the extra feature is done either in the first or the second treatment phase. Which phase is the phase with activated autostimulation will be decided by random selection and the patient does not know when the auxiliary function is started. The study period is 11 months. Patients are asked to fill in some questionnaires on seizures, quality of life and quality of sleep.
- Conditions
- Epilepsy
- Being tested
- Vagus nerv stimulator
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerv stimulatorDevice
pulse triggered autostimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with >25 % change in seizure frequency
Percentage of subjects with >25 % change in seizure frequency
Measured: after 11 month
Secondary outcomes (2)
Change in mean National Hospital Seizure Severity Scale score
Change in mean National Hospital Seizure Severity Scale score (range 1-22 Points, higher values indicate a worse situation)
Measured: after 11 month
Change in mean average seizure duration
Change in mean average seizure duration
Measured: after 11 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start3 Apr 2018
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Why it stopped: for few participants recruited
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.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Filadelfia Epilepsy Hospital, Copenhagen University Hospital, Rigshospitalet, Universitaire Ziekenhuizen KU Leuven, Tampere University Hospital
- Responsible party
- Principal investigator, Oliver Johannes Henning, Oslo University Hospital
- Investigators
- Oliver Henning, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095247
- Sponsor's protocol ID
- 2018/667
- Acronym
- ERAS
- Status last verified
- Oct 2023
- First submitted
- 17 Sep 2019
- Last updated
- 1 Nov 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Additional ECG-triggered Stimulation Increase the Efficacy of Vagus Nerve Stimulation? An Investigator-initiated Prospective, Multinational, Single Blinded, Randomized Cross-over Trial in Patients With VNS-treatment
- ClinicalTrials.gov ID
- NCT04095247
- Acronym / sponsor ID
- ERAS / 2018/667
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: for few participants recruited
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Filadelfia Epilepsy Hospital, Copenhagen University Hospital, Rigshospitalet, Universitaire Ziekenhuizen KU Leuven, Tampere University Hospital
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 19 Sep 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.
This is a research study to investigate whether the use of an extra function of vagus nerve stimulator (VNS) can give an improved effect against epilepsy. Many epileptic seizures are accompanied by an increase in heart rate. One auxiliary function of a new type of stimulator is continuous measurement of cardiac activity, and when pulse rate increases an extra stimulation is delivered. It has been shown that this can interrupt attacks that are about to develop. In this project the investigators will test how well that works for patients in daily life. The new type of stimulator has similar design and location as the old one. Patients who have already been treated with VNS and who need to switch the stimulator because the battery is starting to run out, are asked whether they want to participate. The study is a randomized and blinded cross-over. The activation of the extra feature is done either in the first or the second treatment phase. Which phase is the phase with activated autostimulation will be decided by random selection and the patient does not know when the auxiliary function is started. The study period is 11 months. Patients are asked to fill in some questionnaires on seizures, quality of life and quality of sleep.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible for the study are subjects (males and females) 12 years of age or older who had been using a VNS for at least three years with a positive effect and are getting a device replacement due to low battery capacity or who had a replacement and had not started the additional ECG -triggered stimulation before the study.
Key inclusion criteria (6 listed)
- Subjects, 12 years of age or older, who have a VNS without ECG-triggered auto stimulation implanted, have a positive effect and have a device replacement with model 106 or model 1000 due to low battery capacity,.
- Subjects, who have 2 or more seizure per month and not more than 28 days between seizures during the baseline.
- Subjects, who are on a stable regiment of antiepileptic drug treatment for at least 3 month prior to enrollment and maintain on this regimen throughout the study.
- VNS parameters have not been changed I the last 3 month prior to enrollment.
- Subjects which are using an off time of at least 1.8 min. (If the patient is on a duty cycle involving an off-time of 1.1 min. or less, and willing to participate in the study the duty cycle will have to be changed to fulfill the inclusion criteria as follows. The off-time will be changed to 1.8 min. and the on-time accordingly to achieve about the same duty cycle as the patient had before. If the duty cycle is above 30% the parameters will be changed to 60 sec./1.8 min., if the duty cycle is between 30% and 23% the parameters will be change to 30 sec./1,8 min., if the duty cycle is 20% the parameters will be change to 21 sec./1,8 min. and if the duty cycle is 15% the parameters will be change to 14 sec./1,8 min. After at periode of 3 month observation the patient can be included in the study.)
Key exclusion criteria (2 listed)
- Subjects with rapidly progressive neurodegenerative or rapidly progressing neoplastic disease.
- Subjects or legal guardians who are unable to understand the study procedures.
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 |
|---|---|---|
| Vagus nerv stimulatorpulse triggered autostimulation | Device | – |
Primary outcome
Percentage of subjects with >25 % change in seizure frequency
Time frame: after 11 month
Percentage of subjects with >25 % change in seizure frequency
2 secondary outcomes
Change in mean National Hospital Seizure Severity Scale score
Time frame: after 11 month
Change in mean average seizure duration
Time frame: after 11 month
Results and safety
The study was stopped early (reason given: for few participants recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- 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.
Oliver Henning, MD principal investigator
Oslo University Hospital
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 Oslo University Hospital at 1 site in Norway.
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 6 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: stopped early, as of the sponsor's last update on 1 Nov 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 Norway. 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: for few participants recruited). 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?
Percentage of subjects with >25 % change in seizure frequency (time frame: after 11 month). 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 1 Nov 2023.