EpilepsyLANGLATNCT02799108
Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)
A study testing NIRS and fMRI in people with Epilepsy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Recent data published by various laboratories as well as our preliminary data tend to prove that near-infrared spectroscopy can be used to determine the lateralization of language as part of the preoperative assessment for drug-resistant epilepsy. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- NIRS and fMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Jan 2015
- Phase
- Interventional
- 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
Who may be able to join
- children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated.
Who cannot join
- All children with severe congenital malformation
- Any refusal of a parent or child
- Any child with generalized epilepsy or diffuse interictal spikes
- Any child with a serious deterioration in the general condition and vital functions
- Any child with dermatitis of the face or scalp
- Children under 6 years
Trial locations and contacts
1 site in 1 country.
About this study
Recent data published by various laboratories as well as our preliminary data tend to prove that near-infrared spectroscopy can be used to determine the lateralization of language as part of the preoperative assessment for drug-resistant epilepsy. The reference test used up until very recently was the Wada test, which consisted of injecting an anaesthetic (generally amobarbital sodium) into one of the internal carotid arteries (right or left) in order to determine the predominant cerebral hemisphere for language. This invasive test has been progressively replaced by fMRI, which is nevertheless difficult to perform in children under the age of 7 years. NIRS therefore appears to be a useful alternative, which, in contrast with fMRI, can be easily repeated and allows simple investigation of the various facets of language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have acquired a unique know-how in the field of high-resolution NIRS, both in epilepsy and in the development of language structures.
- Conditions
- Epilepsy
- Being tested
- NIRS, fMRI
- Keywords
- children, language, NIRS
- Medical subject headings
- Epilepsy, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
High-resolution EEG-fNIRS recording lasting a maximum of 30 minutes by using expressive and receptive language paradigms
fMRIDevice
fMRI acquisition under the same stimulation conditions
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated Receives: Device: NIRS; Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
lateralization index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startMay 2012
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: inclusion difficulty
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrince WALLOIS, MD,PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799108
- Sponsor's protocol ID
- AOL11-DR-WALLOIS
- Acronym
- LANGLAT
- Status last verified
- Jun 2016
- First submitted
- 9 Jun 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)
- ClinicalTrials.gov ID
- NCT02799108
- Acronym / sponsor ID
- LANGLAT / AOL11-DR-WALLOIS
- Conditions
- Epilepsy
- Keywords
- children, language, NIRS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion difficulty
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 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.
Recent data published by various laboratories as well as our preliminary data tend to prove that near-infrared spectroscopy can be used to determine the lateralization of language as part of the preoperative assessment for drug-resistant epilepsy. The reference test used up until very recently was the Wada test, which consisted of injecting an anaesthetic (generally amobarbital sodium) into one of the internal carotid arteries (right or left) in order to determine the predominant cerebral hemisphere for language. This invasive test has been progressively replaced by fMRI, which is nevertheless difficult to perform in children under the age of 7 years. NIRS therefore appears to be a useful alternative, which, in contrast with fMRI, can be easily repeated and allows simple investigation of the various facets of language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have acquired a unique know-how in the field of high-resolution NIRS, both in epilepsy and in the development of language structures.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Device: NIRS, Device: fMRIchildren with drug-resistant partial epilepsy, in whom preoperative assessment is indicated |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated.
Key exclusion criteria (6 listed)
- All children with severe congenital malformation
- Any refusal of a parent or child
- Any child with generalized epilepsy or diffuse interictal spikes
- Any child with a serious deterioration in the general condition and vital functions
- Any child with dermatitis 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 |
|---|---|---|
| NIRSHigh-resolution EEG-fNIRS recording lasting a maximum of 30 minutes by using expressive and receptive language paradigms | Device | patients |
| fMRIfMRI acquisition under the same stimulation conditions | Device | patients |
Primary outcome
lateralization index
Time frame: 3 months
Results and safety
The study was stopped early (reason given: inclusion difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
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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.
Fabrince 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?
A study testing NIRS and fMRI in people with 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 1 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: stopped early, as of the sponsor's last update on 14 Jun 2016. 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 was stopped early (reason given: inclusion difficulty). 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?
lateralization index (time frame: 3 months). 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 14 Jun 2016.