EpilepsyNIRS EpilepsieNCT02814331
Electrohaemodynamic Activity in Epileptic Children : Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis
An observational study of Epilepsy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis to spatial localization of epileptogenic foci Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- multimodal high-resolution EEG-NIRS
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2011to 24 Apr 2015
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children between the ages of 6 and 18 years with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.
Who may be able to join
- Children between the ages of 6 and 18 years
- with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.
Who cannot join
- Children with a serious congenital malformation.
- Refusal from one of the parents or the child.
- Children with generalized epilepsy or diffuse interictal spikes.
- Children with severely impaired general status and vital functions.
- Children with dermatosis of the face or scalp.
- Children under the age of 6 years or adults over the age of 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrohaemodynamic Activity in Epileptic Children: Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis
Evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis to spatial localization of epileptogenic foci
Read the detailed description
This study is designed to evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of epileptogenic foci in order to perform multimodal mapping and localization of interictal spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG electrode implantation strategy prior to surgery in children with drug-refractory partial epilepsy.
- Conditions
- Epilepsy
- Being tested
- multimodal high-resolution EEG-NIRS
- Keywords
- Video-EEG, near-infrared spectroscopy (NIRS)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal high-resolution EEG-NIRSDevice
| Study group | Role | What they receive |
|---|---|---|
| symptomatic partial epilepsy | whose brain MRI is abnormal multimodal high-resolution EEG-NIRS Receives: Device: multimodal high-resolution EEG-NIRS | |
| not symptomatic partial epilepsy | whose brain MRI is normal multimodal high-resolution EEG-NIRS Receives: Device: multimodal high-resolution EEG-NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
multimodal high-resolution EEG-NIRS
to evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of epileptogenic foci in order to perform multimodal mapping and localization of interictal spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG electrode implantation strategy prior to surgery in children with drug-refractory partial epilepsy.
Measured: Day 0
Secondary outcomes (1)
Functional MRI
to analyse the temporal dynamics of haemodynamic changes surrounding epileptic spikes.
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 posted27 Jun 2016 (estimated)
- Study start14 Oct 2011
- Primary completion24 Apr 2015
- Study completion24 Apr 2015
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
- 23 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
- NCT02814331
- Sponsor's protocol ID
- PHRCN11-DR-WALLOIS
- Acronym
- NIRS Epilepsie
- Status last verified
- Aug 2018
- First submitted
- 23 Jun 2016
- Last updated
- 3 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrohaemodynamic Activity in Epileptic Children: Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis
- ClinicalTrials.gov ID
- NCT02814331
- Acronym / sponsor ID
- NIRS Epilepsie / PHRCN11-DR-WALLOIS
- Conditions
- Epilepsy
- Keywords
- Video-EEG, near-infrared spectroscopy (NIRS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 14 Oct 2011 (actual)
- Primary completion
- 24 Apr 2015 (actual)
- Study completion
- 24 Apr 2015 (actual)
- First posted
- 27 Jun 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.
Evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis to spatial localization of epileptogenic foci
Detailed description
This study is designed to evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of epileptogenic foci in order to perform multimodal mapping and localization of interictal spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG electrode implantation strategy prior to surgery in children with drug-refractory partial epilepsy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| symptomatic partial epilepsy | – | Device: multimodal high-resolution EEG-NIRSwhose brain MRI is abnormal multimodal high-resolution EEG-NIRS |
| not symptomatic partial epilepsy | – | Device: multimodal high-resolution EEG-NIRSwhose brain MRI is normal multimodal high-resolution EEG-NIRS |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children between the ages of 6 and 18 years with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.
Key inclusion criteria (2 listed)
- Children between the ages of 6 and 18 years
- with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.
Key exclusion criteria (6 listed)
- Children with a serious congenital malformation.
- Refusal from one of the parents or the child.
- Children with generalized epilepsy or diffuse interictal spikes.
- Children with severely impaired general status and vital functions.
- Children with dermatosis of the face or 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 |
|---|---|---|
| multimodal high-resolution EEG-NIRS | Device | not symptomatic partial epilepsy, symptomatic partial epilepsy |
Primary outcome
multimodal high-resolution EEG-NIRS
Time frame: Day 0
to evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of epileptogenic foci in order to perform multimodal mapping and localization of interictal spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG electrode implantation strategy prior to surgery in children with drug-refractory partial epilepsy.
1 secondary outcome
Functional MRI
Time frame: Day 0
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 3 Aug 2018.
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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
1 site 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 1 site 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 2 inclusion and 6 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 3 Aug 2018. 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 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?
multimodal high-resolution EEG-NIRS (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 3 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.