Epileptic EncephalopathyIBISNCT07585643
IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).
An observational study of Epileptic Encephalopathy and Early Infantile Epileptic Encephalopathy, run by Telethon Kids Institute at 2 sites in 2 countries.
Trial summary
When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG). Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy, Infantile Spasm
- What is being tested?
- Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Sep 2026to 4 Sep 2029
- Phase
- Observational
- 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 0 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: 20 eligible patients identified by the neurology department at Perth Children's Hospital and 20 eligible patients identified by the neurology department at Hospital das Clinicas HCFMUSP, Faculdade de Medicina, will be approached for the study.
Who may be able to join
- Children (<16 years old) with a confirmed diagnosis of early onset EE or DEE due to any cause (prior to age 2 years).
Who cannot join
- Language barriers impeding data collection
- Department for Child Protection and Family Support is involved in the care of the child.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Britta S von Ungern-Sternberg, MD, PhD contact
2 sites in 2 countries
Australia1 site
Perth Children's Hospital
Perth, Western Australia, 6909
Britta S von Ungern-Sternberg, MD, PhD, +61 8 6456 4806, britta.regli-vonungern@health.wa.gov.au
Lliana Slevin, BSc, +61 426 952 977, lliana.slevin@thekids.org.au
Brazil1 site
Hospital das Clinicas, São Paulo, Sao Paulo
São Paulo
Vinícius Quintão, MD PHD, +55 11 2661 5795, vinicius.quintao@hc.fm.usp.br
About this study
When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG). These monitors are routinely used in paediatric anaesthesia; however, investigators do not know if they work accurately in babies and young children with seizure disorders or on anti-seizure medications.
Children with developmental and epileptic encephalopathies may need anaesthesia for tests or procedures. It is important that their treating doctors understand whether these monitors truly reflect how awake or asleep the children are. This study aims to compare a child's electrical brain activity using two commonly used devices in paediatric anaesthesia with the conventional 21-lead EEG patterns in children with seizure disorders. The results of this research may help improve the safety and perioperative care of children with seizure disorders who require general anaesthesia in the future.
Read the detailed description
There is currently no available data on the reliability of processed electroencephalogram (pEEG) for adequately predicting depth of anaesthesia (DOA) with abnormal electroencephalogram (EEG) and those on anticonvulsant medication. Examples of epilepsy syndromes in which seizures and abnormal EEG (abnormal backgrounds: including excess discontinuity, excess slow, low amplitude, lack of sleep stages, and frequent epileptiform discharges) are predominant features are Early Infantile Developmental and Epileptic Encephalopathy (EIDEE), Epilepsy of infancy with Migrating Focal Seizures (EIMFS), Infantile Spasm Syndrome (IS) and other Epileptic encephalopathies (EE) and Developmental and Epileptic Encephalopathy (DEE). Considering the use of pEEG is common in paediatric anaesthesia and one of the strategies used to precent awareness and excessive anaesthesia provision, it would be pertinent to examine whether pEEG values truly reflect depth of sedation of these infants or if they are artificially low or high. To this end, investigators aim to concurrently measure EEG and pEEG patterns in infants with DEEs with onset in infancy and early childhood. Both pEEG patterns and their values will be measured with two commonly used monitors- the BiSpectral Index (BIS) and Sedline. Data from both pEEG monitors can then be directly compared with contemporaneous conventional EEG patterns on each patient.
This study will be conducted in collaboration with paediatric anaesthetists and neurologists in Perth Children's Hospital, Western Australia and the Hospital das Clínicas, Faculty of Medicine, University of São Paulo, Brazil. The target sample size is 40 participants- 20 from each centre. Participants will be invited to visit the hospital. Each awake participant will be fitted with a 16-lead EEG and additionally a BIS or Sedline monitor, applied consecutively in random order. The measurement period will be 30 minutes for each of the BIS and the Sedline with continuous EEG assessment throughout. This will allow the pEEG data to be measured against a corresponding continuous EEG.
- Conditions
- Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy, Infantile Spasm, Developmental and Epileptic Encephalopathies
- Being tested
- Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.
- Keywords
- epileptic encepthalopathy, anaesthesia, PILOT STUDY, MULTICENTRE
- Medical subject headings
- Infantile Epileptic-Dyskinetic Encephalopathy, Spasms, Infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.Diagnostic test
This is an observational study of children under 16 years of age, who will be fitted with a 21-lead EEG and then, in consecutive random order, a BIS or Sedline monitor with measurements taken for 30 minutes with each monitor, 60 min in total. This will allow pEEG data to be measured against a corresponding continuous EEG.
The depth of anaesthesia monitors used are Bispectral Index (BIS, Medtronic, Minneapolis, Minnesota, USA) and Sedline (Masimo, Irvine, California, USA).
| Study group | Role | What they receive |
|---|---|---|
| Children (<16 years) with confirmed diagnosis of early onset EE or DEE due to any cause | Children (<16 years old) with a confirmed diagnosis of early onset epileptic encephalopathy (EE) or Developmental and epileptic encephalopathy (DEE) due to any cause (prior to age 2 years). Receives: Diagnostic Test: Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare pEEG values in awake patients with developmental and epileptic encephalopathies
pEEG will be measured using Sedline and BIS monitors alongside standard 21-lead EEG.
Measured: 60 minutes of monitoring in total - Sedline and BIS monitors will be fitted for 30 minutes each, in consecutive random order.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start3 Sep 2026 (estimated)
- Primary completion3 Sep 2029 (estimated)
- Study completion4 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epileptic EncephalopathyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telethon Kids Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Child and Adolescent Health Service - Perth, Feculdade de Medicina da Universidade de Sao Paulo - Brasil, University of Sao Paulo General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585643
- Sponsor's protocol ID
- RGS0000008394
- Acronym
- IBIS
- Status last verified
- Apr 2026
- First submitted
- 6 May 2026
- Last updated
- 17 Jul 2026
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IBIS - Investigating Reliability of BIS and SEDLINE Monitoring in Children With Developmental and Epileptic Encephalopathies (DEE).
- ClinicalTrials.gov ID
- NCT07585643
- Acronym / sponsor ID
- IBIS / RGS0000008394
- Conditions
- Epileptic Encephalopathy, Early Infantile Epileptic Encephalopathy, Infantile Spasm, Developmental and Epileptic Encephalopathies
- Keywords
- epileptic encepthalopathy, anaesthesia, PILOT STUDY, MULTICENTRE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Telethon Kids InstituteUniversity, hospital or other
- Collaborators
- Child and Adolescent Health Service - Perth, Feculdade de Medicina da Universidade de Sao Paulo - Brasil, University of Sao Paulo General Hospital
- Study start
- 3 Sep 2026 (estimated)
- Primary completion
- 3 Sep 2029 (estimated)
- Study completion
- 4 Sep 2029 (estimated)
- First posted
- 14 May 2026 (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.
When children have surgery, anaesthetists carefully monitor the depth of anaesthesia by using sensors on the forehead that measure brain activity, also known as processed electroencephalogram (pEEG). These monitors are routinely used in paediatric anaesthesia; however, investigators do not know if they work accurately in babies and young children with seizure disorders or on anti-seizure medications.
Children with developmental and epileptic encephalopathies may need anaesthesia for tests or procedures. It is important that their treating doctors understand whether these monitors truly reflect how awake or asleep the children are. This study aims to compare a child's electrical brain activity using two commonly used devices in paediatric anaesthesia with the conventional 21-lead EEG patterns in children with seizure disorders. The results of this research may help improve the safety and perioperative care of children with seizure disorders who require general anaesthesia in the future.
Detailed description
There is currently no available data on the reliability of processed electroencephalogram (pEEG) for adequately predicting depth of anaesthesia (DOA) with abnormal electroencephalogram (EEG) and those on anticonvulsant medication. Examples of epilepsy syndromes in which seizures and abnormal EEG (abnormal backgrounds: including excess discontinuity, excess slow, low amplitude, lack of sleep stages, and frequent epileptiform discharges) are predominant features are Early Infantile Developmental and Epileptic Encephalopathy (EIDEE), Epilepsy of infancy with Migrating Focal Seizures (EIMFS), Infantile Spasm Syndrome (IS) and other Epileptic encephalopathies (EE) and Developmental and Epileptic Encephalopathy (DEE). Considering the use of pEEG is common in paediatric anaesthesia and one of the strategies used to precent awareness and excessive anaesthesia provision, it would be pertinent to examine whether pEEG values truly reflect depth of sedation of these infants or if they are artificially low or high. To this end, investigators aim to concurrently measure EEG and pEEG patterns in infants with DEEs with onset in infancy and early childhood. Both pEEG patterns and their values will be measured with two commonly used monitors- the BiSpectral Index (BIS) and Sedline. Data from both pEEG monitors can then be directly compared with contemporaneous conventional EEG patterns on each patient.
This study will be conducted in collaboration with paediatric anaesthetists and neurologists in Perth Children's Hospital, Western Australia and the Hospital das Clínicas, Faculty of Medicine, University of São Paulo, Brazil. The target sample size is 40 participants- 20 from each centre. Participants will be invited to visit the hospital. Each awake participant will be fitted with a 16-lead EEG and additionally a BIS or Sedline monitor, applied consecutively in random order. The measurement period will be 30 minutes for each of the BIS and the Sedline with continuous EEG assessment throughout. This will allow the pEEG data to be measured against a corresponding continuous EEG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children (<16 years) with confirmed diagnosis of early onset EE or DEE due to any cause | – | Diagnostic Test: Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.Children (<16 years old) with a confirmed diagnosis of early onset epileptic encephalopathy (EE) or Developmental and epileptic encephalopathy (DEE) due to any cause (prior to age 2 years). |
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 20 eligible patients identified by the neurology department at Perth Children's Hospital and 20 eligible patients identified by the neurology department at Hospital das Clinicas HCFMUSP, Faculdade de Medicina, will be approached for the study.
Key inclusion criteria (1 listed)
- Children (<16 years old) with a confirmed diagnosis of early onset EE or DEE due to any cause (prior to age 2 years).
Key exclusion criteria (2 listed)
- Language barriers impeding data collection
- Department for Child Protection and Family Support is involved in the care of the child.
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 |
|---|---|---|
| Monitoring of patients using electroencephalogram, a Bispectral Index (BIS) and Sedline monitors.This is an observational study of children under 16 years of age, who will be fitted with a 21-lead EEG and then, in consecutive random order, a BIS or Sedline monitor with measurements taken for 30 minutes with each monitor, 60 min in total. This will allow pEEG data to be measured against a corresponding continuous EEG. The depth of anaesthesia monitors used are Bispectral Index (BIS, Medtronic, Minneapolis, Minnesota, USA) and Sedline (Masimo, Irvine, California, USA). | Diagnostic test | Children (<16 years) with confirmed diagnosis of early onset EE or DEE due to any cause |
Primary outcome
Compare pEEG values in awake patients with developmental and epileptic encephalopathies
Time frame: 60 minutes of monitoring in total - Sedline and BIS monitors will be fitted for 30 minutes each, in consecutive random order.
pEEG will be measured using Sedline and BIS monitors alongside standard 21-lead EEG.
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 17 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Epileptic Encephalopathy
Not yet recruitingPhase 3
Open-label, Single-arm Trial of Ganaxolone in CDD Patients 6 Months to Less Than 2 Years Old
CDKL5 Deficiency Disorder
RecruitingObservational study
Multi-biomarkers in DEE
Developmental and Epileptic Encephalopathies (DEE)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Dravet Syndrome
RecruitingPhase 1/2
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
Dravet Syndrome
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.
Britta S von Ungern-Sternberg, MD, PhD contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epileptic Encephalopathy and Early Infantile Epileptic Encephalopathy, run by Telethon Kids Institute at 2 sites in 2 countries.
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 1 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: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Brazil. 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?
Contact Britta S von Ungern-Sternberg, MD, PhD (+61 8 6456 4806, britta.regli-vonungern@health.wa.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare pEEG values in awake patients with developmental and epileptic encephalopathies (time frame: 60 minutes of monitoring in total - Sedline and BIS monitors will be fitted for 30 minutes each, in consecutive random order.). 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 17 Jul 2026.