EpilepsySPASMES-NIRSNCT02899832
A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms
An observational study of Epilepsy, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- NIRS
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Feb 2013to 13 Feb 2020
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between 3 and 6 years old presenting infantile spasms
Who may be able to join
- Children between 3 and 6 years old presenting infantile spasms according to the Classification of the International League Against Epilepsy
Who cannot join
- Children younger than 3 months and older than 6 years of age, refusal of one of the parents, and dermatosis of the scalp
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Amiens
Amiens, 80054
Fondation Ophtalmologique Rothshild
Paris, 75019
About this study
This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording.
This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).
Read more
Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function.
This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians
- Conditions
- Epilepsy
- Being tested
- NIRS
- Keywords
- children, spasms
- Medical subject headings
- Epilepsy, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
Near Infra Red Spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| NIRS | Near Infra Red Spectroscopy. Receives: Device: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in HbO
hemodynamic changes in [HbO] before spasms, during spasms, and after spasms
Measured: Day 0
changes in Hbr
hemodynamic changes in [Hbr] before spasms, during spasms, and after spasms
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 posted14 Sep 2016 (estimated)
- Study start21 Feb 2013
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
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 Centre Hospitalier Universitaire, AmiensThe 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 only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice WALLOIS, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899832
- Sponsor's protocol ID
- PI2012_843_0029
- Acronym
- SPASMES-NIRS
- Status last verified
- Jun 2026
- First submitted
- 5 Sep 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms
- ClinicalTrials.gov ID
- NCT02899832
- Acronym / sponsor ID
- SPASMES-NIRS / PI2012_843_0029
- Conditions
- Epilepsy
- Keywords
- children, spasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 21 Feb 2013 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 14 Sep 2016 (estimated)
- 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 study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording.
This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).
Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function.
This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRS | – | Device: NIRSNear Infra Red Spectroscopy. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between 3 and 6 years old presenting infantile spasms
Key inclusion criteria (1 listed)
- Children between 3 and 6 years old presenting infantile spasms according to the Classification of the International League Against Epilepsy
Key exclusion criteria (1 listed)
- Children younger than 3 months and older than 6 years of age, refusal of one of the parents, and dermatosis of the scalp
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 |
|---|---|---|
| NIRSNear Infra Red Spectroscopy | Device | NIRS |
Primary outcome
changes in HbO
Time frame: Day 0
hemodynamic changes in [HbO] before spasms, during spasms, and after spasms
changes in Hbr
Time frame: Day 0
hemodynamic changes in [Hbr] before spasms, during spasms, and after spasms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
Fabrice WALLOIS, MD, PhD principal investigator
CHU Amiens
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 Centre Hospitalier Universitaire, Amiens 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jun 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
changes in HbO (time frame: Day 0). The study lists 2 primary outcomes in all. 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 12 Jun 2026.