Epilepsy (Treatment Refractory)ECLIPSENCT06952764
Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)
A study testing Seizure risk forecast in people with Epilepsy (Treatment Refractory), run by Insel Gruppe AG, University Hospital Bern at 1 site in United States.
Trial summary
The occurrence of seizures in epilepsy is not entirely random. Temporal patterns that organize the occurrence of seizures over weeks and months were previously unraveled using intracranial EEG System (IEEG) that monitors epileptic brain activity chronically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy (Treatment Refractory)
- What is being tested?
- Seizure risk forecast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with diagnosed pharmacoresistant epilepsy and at least one self-reported seizure in the last 12 months.
- Patients previously implanted with the RNS System, on stable detection settings enabling reliable detection of electrographic seizures.
- Patients willing and able to keep a diary, issue self-forecasts, and follow instructions.
- Home equipped with an internet connection.
- Informed Consent signed by the subject
Who cannot join
- Insufficient number of electrographic seizures or insufficient forecasting performance in the training phase.
- Women pregnant at the time of recruitment (later pregnancy not a contra-indication)
- Subjects with a history of psychogenic non-epileptic seizures
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Vulnerable subjects, including severe cognitive impairment precluding informed consent
- Drug or alcohol addiction
- Subjects who are unable (i.e., mentally or physically impaired patients) or do not have the necessary assistance, to properly operate the device system.
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
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation, A Double-blinded Study of Seizure Forecasting and Randomized Information Withdrawal in Adults With Epilepsy.
The occurrence of seizures in epilepsy is not entirely random. Temporal patterns that organize the occurrence of seizures over weeks and months were previously unraveled using intracranial EEG System (IEEG) that monitors epileptic brain activity chronically. Seizures typically recur with patient-specific periodicity and are preceded by increases of epileptic brain activity over days. Here, the investigators developed new methods to forecast seizure likelihoods at a 24-h horizon. In this trial, participants will be provided with daily estimates about their upcoming risk of seizures. As a primary outcome, the performance of forecasts will be evaluated against the occurrence of electrographic seizures. As secondary outcome, the forecast's potential benefit for users in conveying actionable information in real-life will be assessed.
- Conditions
- Epilepsy (Treatment Refractory)
- Being tested
- Seizure risk forecast, Control seizure risk forecast
- Keywords
- Seizure forecasting
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seizure risk forecastOther
Participants are provided with daily risk estimates about upcoming seizure likelihood.
Control seizure risk forecastOther
Participant receive uninformative control forecast
| Study group | Role | What they receive |
|---|---|---|
| IEEG-forecast | Experimental | Potentially informative seizure forecast. Receives: Other: Seizure risk forecast |
| Control-forecast | Active comparator | Uninformative control seizure forecast. Receives: Other: Control seizure risk forecast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forecast performance
Performance of double-blinded (covert phase) IEEG-forecasts. Performance is quantified as the area-under-the sensitivity vs. time in warning curve (AUC) and double-tested statistically in a pairwise manner against shuffled chance-forecasts and participant's self-forecasts.
Measured: At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment.
Secondary outcomes (4)
Maintenance of forecast performance
For the cohort that progresses to the overt phase, The AUC obtained during the overt phase will be compared to their historical AUC during the covert phase and tested for a pairwise difference.
Measured: At least 8 seizures during the overt phase, expected to last 6-12 months
Informativity
Participant-reported estimates of how informative a forecast is on a visual-analogue scale, scored from 0 to 10.
Measured: Throughout the open-label (6-12 months) and withdrawal phase (3-6 months)
QOLIE-31
Quality Of Life In Epilepsy questionnaires with 31 items (QOLIE-31) completed at the transition from one study phase to the next. The quantification is on a scale from 0 to 100 and pairwise comparison between covert, overt and withdrawal phase.
Measured: Upon completion of the study after 18-30 months.
Actionability
List of concrete strategies enabled by the forecasts
Measured: End of open-label phase after 12-24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy (Treatment Refractory)Studies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three sequential phases: 1. Covert phase: double-blinded (participant, investigator) 2. Overt phase: open-label 3. Withdrawal phase: double-blinded (participant, investigator), randomized, controlled, cross-over withdrawal of seizure forecast
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Maxime O Baud, MD, PhD, Study chair, Department of Neurology, Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952764
- Sponsor's protocol ID
- 2025 - SWEZ01
- Acronym
- ECLIPSE
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data can be shared by the investigators upon study completion based on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation, A Double-blinded Study of Seizure Forecasting and Randomized Information Withdrawal in Adults With Epilepsy.
- ClinicalTrials.gov ID
- NCT06952764
- Acronym / sponsor ID
- ECLIPSE / 2025 - SWEZ01
- Conditions
- Epilepsy (Treatment Refractory)
- Keywords
- Seizure forecasting
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 May 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 occurrence of seizures in epilepsy is not entirely random. Temporal patterns that organize the occurrence of seizures over weeks and months were previously unraveled using intracranial EEG System (IEEG) that monitors epileptic brain activity chronically. Seizures typically recur with patient-specific periodicity and are preceded by increases of epileptic brain activity over days. Here, the investigators developed new methods to forecast seizure likelihoods at a 24-h horizon. In this trial, participants will be provided with daily estimates about their upcoming risk of seizures. As a primary outcome, the performance of forecasts will be evaluated against the occurrence of electrographic seizures. As secondary outcome, the forecast's potential benefit for users in conveying actionable information in real-life will be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Three sequential phases: 1. Covert phase: double-blinded (participant, investigator) 2. Overt phase: open-label 3. Withdrawal phase: double-blinded (participant, investigator), randomized, controlled, cross-over withdrawal of seizure forecast
| Arm | Type | Receives |
|---|---|---|
| IEEG-forecast | Experimental | Other: Seizure risk forecastPotentially informative seizure forecast. |
| Control-forecast | Active comparator | Other: Control seizure risk forecastUninformative control seizure forecast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult with diagnosed pharmacoresistant epilepsy and at least one self-reported seizure in the last 12 months.
- Patients previously implanted with the RNS System, on stable detection settings enabling reliable detection of electrographic seizures.
- Patients willing and able to keep a diary, issue self-forecasts, and follow instructions.
- Home equipped with an internet connection.
- Informed Consent signed by the subject
Key exclusion criteria (7 listed)
- Insufficient number of electrographic seizures or insufficient forecasting performance in the training phase.
- Women pregnant at the time of recruitment (later pregnancy not a contra-indication)
- Subjects with a history of psychogenic non-epileptic seizures
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Vulnerable subjects, including severe cognitive impairment precluding informed consent
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 |
|---|---|---|
| Seizure risk forecastParticipants are provided with daily risk estimates about upcoming seizure likelihood. | Other | IEEG-forecast |
| Control seizure risk forecastParticipant receive uninformative control forecast | Other | Control-forecast |
Primary outcome
Forecast performance
Time frame: At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment.
Performance of double-blinded (covert phase) IEEG-forecasts. Performance is quantified as the area-under-the sensitivity vs. time in warning curve (AUC) and double-tested statistically in a pairwise manner against shuffled chance-forecasts and participant's self-forecasts.
4 secondary outcomes
Maintenance of forecast performance
Time frame: At least 8 seizures during the overt phase, expected to last 6-12 months
Informativity
Time frame: Throughout the open-label (6-12 months) and withdrawal phase (3-6 months)
QOLIE-31
Time frame: Upon completion of the study after 18-30 months.
Actionability
Time frame: End of open-label phase after 12-24 months.
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 1 May 2025.
- Individual participant dataSharing planned: Yes. The individual participant data can be shared by the investigators upon study completion based on a reasonable request.
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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.
Maxime O Baud, MD, PhD study chair
Department of Neurology, Inselspital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seizure risk forecast in people with Epilepsy (Treatment Refractory), run by Insel Gruppe AG, University Hospital Bern 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 5 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: enrolling by invitation, as of the sponsor's last update on 1 May 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?
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?
Forecast performance (time frame: At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment.). 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 May 2025.