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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in France

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.

  1. 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.

  1. First posted19 May 2023
  2. Study start3 Feb 2024
  3. Primary completion29 May 2026
  4. Study completion29 May 2026

Why it stopped: Insufficient enrollement of patients

Resources

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)
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

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.

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