EpilepsyICONENCT05865561
Identification of Volatile Organic Compounds (VOCs) as Biopredictors of Epileptic Seizures
An observational study of Epilepsy, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial summary
The unpredictable nature of epileptic seizures places people with epilepsy under permanent psychological stress, which contributes significantly to a restriction in their quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- VOC sampling
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Feb 2024to 29 May 2026
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The epileptics will be recruited by the neurologists from among the epileptics treated at the Institut la Teppe and the Fondation A de Rothschild Hospital who meet the selection criteria.
Who may be able to join
- Person at least 18 years of age
- With drug-resistant epilepsy according to the ILAE criteria
- With one of the following 3 types of seizures :
- Focal seizures Focal seizures with secondary generalization Generalized seizures - motor or non-motor
- Requiring at least 48 hours of video-EEG
- Consent to participate in the study from the patient and his/her legal guardian, if applicable
- Affiliated or beneficiary of a social security plan
Who cannot join
- Person with epilepsy benefiting from a legal protection measure other than curatorship or guardianship
- Pregnant or breastfeeding woman
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Fondation Adolphe de Rothschild
Paris, 75019
Institut La Teppe
Tain-l'Hermitage, 26600
About this study
The unpredictable nature of epileptic seizures places people with epilepsy under permanent psychological stress, which contributes significantly to a restriction in their quality of life. The possibility of predicting the arrival of epileptic seizures would allow, in addition to taking a preventive treatment if the risk of seizure is close, to prevent traumas and accidents linked to possible falls during seizures, to authorize driving for certain people with epilepsy and to reduce the costs of medical care. To date and to our knowledge, no seizure detection device has been commercialized. There are commercialized devices based on biometric sensors other than EEG, but these are strictly dedicated to the detection of seizures and do not allow the anticipation of seizures. Regarding prediction, current research seems to have difficulties in developing convincing algorithms. The only system used successfully in real time would require a device implantable in the brain, but this would raise problems of acceptability.
In addition, 20% of people with drug-resistant epilepsy have psychogenic non-epileptic seizures (PNES). These are sometimes difficult to differentiate from epileptic seizures by people with epilepsy and their caregivers, and their management differs from that of epileptic seizures. The distinction between these 2 types of events should also be taken into account by these prediction/detection tools.
Read more
From the field of biomedical detection dogs, there is currently a converging body of evidence supporting that people with epilepsy emit specific odors associated with seizure events. Trained dogs have been shown to be able to discriminate body odors sampled during or just after an epileptic seizure from those sampled from the same subjects in various contexts outside of a seizure. It was also shown that a seizure can also be predicted by the volatile organic compounds (VOCs) released by the patient (human volatilome); the olfactory signature being already detectable up to 3h before a seizure. Another study used trained dogs to confirm that they are able to detect a seizure by smell and that this olfactory difference is already detectable before a seizure.
The human volatilome VOCs lead is particularly promising, notably for its non-invasiveness and for the pre-ictal precocity that prediction allows. But at the moment, the studies are too studies are too preliminary, with sample sizes too small to conclude on the inter-individual generalization of the odor, taking into account the type of seizure involved and the influence of other variables (e.g., gender, age, medications). Moreover, in order to develop a reliable and transportable electronic detection tool, the identification of the VOCs involved is necessary, since the choice of sensors (e.g., to constitute an electronic nose) depends on it. The objective of this study is to overcome these shortcomings, by aiming at the identification of the informative odor(s) associated with epileptic events during the pre-ictal, ictal and post-ictal periods, taking into account the type of seizures (focal seizures, secondary generalized focal seizures, primary generalized seizures - motor and non-motor) and the inter-individual differences.
- Conditions
- Epilepsy
- Being tested
- VOC sampling
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOC samplingOther
- Continuous systematic sampling at HFAR: Samples every 3 hours (3 a.m., 6 a.m., 9 a.m., 12 p.m., 3 p.m., 6 p.m., 9 p.m., midnight) until the end of the monitoring period.
- Systematic sampling during the day: Samples every 3 hours at Institut La TEPPE (9am, 12pm, 3pm, 6pm, 9pm) until the end of the follow-up period.
- Sampling in case of epileptic seizure : Sampling during the seizure (from t0 to t+5 min), whatever the time.
The samples will be taken using a compress on the forehead, the palms of the hands and the back of the neck. The compress will then be placed in a freezer bag and the person with epilepsy will be asked to exhale into the bag, if he/she is able to do so, before closing it.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of human volatile organic compounds (VOCs) biopredictors of epileptic seizures.
Distribution of molecules or pieces of molecules per sample.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start3 Feb 2024
- Primary completion29 May 2026
- Study completion29 May 2026
Why it stopped: Insufficient enrollement of patients
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 Fondation Ophtalmologique Adolphe de RothschildThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865561
- Sponsor's protocol ID
- PLR_2022_12
- Acronym
- ICONE
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Volatile Organic Compounds (VOCs) as Biopredictors of Epileptic Seizures
- ClinicalTrials.gov ID
- NCT05865561
- Acronym / sponsor ID
- ICONE / PLR_2022_12
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient enrollement of patients
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 19 May 2023 (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 unpredictable nature of epileptic seizures places people with epilepsy under permanent psychological stress, which contributes significantly to a restriction in their quality of life. The possibility of predicting the arrival of epileptic seizures would allow, in addition to taking a preventive treatment if the risk of seizure is close, to prevent traumas and accidents linked to possible falls during seizures, to authorize driving for certain people with epilepsy and to reduce the costs of medical care. To date and to our knowledge, no seizure detection device has been commercialized. There are commercialized devices based on biometric sensors other than EEG, but these are strictly dedicated to the detection of seizures and do not allow the anticipation of seizures. Regarding prediction, current research seems to have difficulties in developing convincing algorithms. The only system used successfully in real time would require a device implantable in the brain, but this would raise problems of acceptability.
In addition, 20% of people with drug-resistant epilepsy have psychogenic non-epileptic seizures (PNES). These are sometimes difficult to differentiate from epileptic seizures by people with epilepsy and their caregivers, and their management differs from that of epileptic seizures. The distinction between these 2 types of events should also be taken into account by these prediction/detection tools.
From the field of biomedical detection dogs, there is currently a converging body of evidence supporting that people with epilepsy emit specific odors associated with seizure events. Trained dogs have been shown to be able to discriminate body odors sampled during or just after an epileptic seizure from those sampled from the same subjects in various contexts outside of a seizure. It was also shown that a seizure can also be predicted by the volatile organic compounds (VOCs) released by the patient (human volatilome); the olfactory signature being already detectable up to 3h before a seizure. Another study used trained dogs to confirm that they are able to detect a seizure by smell and that this olfactory difference is already detectable before a seizure.
The human volatilome VOCs lead is particularly promising, notably for its non-invasiveness and for the pre-ictal precocity that prediction allows. But at the moment, the studies are too studies are too preliminary, with sample sizes too small to conclude on the inter-individual generalization of the odor, taking into account the type of seizure involved and the influence of other variables (e.g., gender, age, medications). Moreover, in order to develop a reliable and transportable electronic detection tool, the identification of the VOCs involved is necessary, since the choice of sensors (e.g., to constitute an electronic nose) depends on it. The objective of this study is to overcome these shortcomings, by aiming at the identification of the informative odor(s) associated with epileptic events during the pre-ictal, ictal and post-ictal periods, taking into account the type of seizures (focal seizures, secondary generalized focal seizures, primary generalized seizures - motor and non-motor) and the inter-individual differences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The epileptics will be recruited by the neurologists from among the epileptics treated at the Institut la Teppe and the Fondation A de Rothschild Hospital who meet the selection criteria.
Key inclusion criteria (7 listed)
- Person at least 18 years of age
- With drug-resistant epilepsy according to the ILAE criteria
- With one of the following 3 types of seizures :
- Focal seizures Focal seizures with secondary generalization Generalized seizures - motor or non-motor
- Requiring at least 48 hours of video-EEG
Key exclusion criteria (2 listed)
- Person with epilepsy benefiting from a legal protection measure other than curatorship or guardianship
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| VOC sampling* Continuous systematic sampling at HFAR: Samples every 3 hours (3 a.m., 6 a.m., 9 a.m., 12 p.m., 3 p.m., 6 p.m., 9 p.m., midnight) until the end of the monitoring period. * Systematic sampling during the day: Samples every 3 hours at Institut La TEPPE (9am, 12pm, 3pm, 6pm, 9pm) until the end of the follow-up period. * Sampling in case of epileptic seizure : Sampling during the seizure (from t0 to t+5 min), whatever the time. The samples will be taken using a compress on the forehead, the palms of the hands and the back of the neck. The compress will then be placed in a freezer bag and the person with epilepsy will be asked to exhale into the bag, if he/she is able to do so, before closing it. | Other | – |
Primary outcome
Identification of human volatile organic compounds (VOCs) biopredictors of epileptic seizures.
Time frame: Day 0
Distribution of molecules or pieces of molecules per sample.
Results and safety
The study was stopped early (reason given: Insufficient enrollement of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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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.
2 sites 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 Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
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 7 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 7 Oct 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 France. 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: Insufficient enrollement of patients). 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?
Identification of human volatile organic compounds (VOCs) biopredictors of epileptic seizures. (time frame: Day 0). 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 7 Oct 2026.