OligoastrocytomaBNLNCT02903784
Neural Basis of Language Processing
A study testing fMRI, tractography and neuropsychological examination in people with Oligoastrocytoma and Astrocytoma, run by University Hospital, Montpellier.
Trial summary
According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly progressive, infiltrating the central nervous system, mainly affecting young adults. This surgery should nevertheless be conducted in awake condition to achieve two conflicting goals: get maximum brain tissue infiltrated by the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oligoastrocytoma, Astrocytoma, Oligodendroglioma
- What is being tested?
- fMRI, tractography and neuropsychological examination
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Sep 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients carry a grade glioma 2 functional area of language and presenting the information to receive surgical care provided in awake for the first time.
- or Healthy volunteers will be selected using a matching age and sex of patients in the study (matched to a patient on two of the first forty patients).
Who cannot join
- Subject presenting cons-indications to MRI (ventricular shunt valve, ferromagnetic foreign bodies, pacemaker, implantable defibrillators, cochlear hearing implant, claustrophobia, ....)
- History of head trauma, ischemic stroke or intracerebral hematoma.
About this study
Official title: The Neural Basis of Language: A New Lighting. Study of Semantic Processing in MRI Mutimodale and Direct Electrical Stimulation
According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly progressive, infiltrating the central nervous system, mainly affecting young adults.
This surgery should nevertheless be conducted in awake condition to achieve two conflicting goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of functional structures. So awake after opening the skull, the patient undergoes a series of preoperative tests, administered by a speech therapist present in the operating room. This procedure allows the neurosurgeon to establish an individual functional brain mapping in real time, through the observation by the SLP of the patient's answers to direct electrical stimulation applied to the cortical and sub-cortical. This support is based on the extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive lesion. To ensure the patient the highest achievable load should increase our understanding of brain function, including the neural bases of language, glioma grade 2 is predominantly localized functional area of language.
Read the detailed description
According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly progressive, infiltrating the central nervous system, mainly affecting young adults. Surgical excision of the tumor is the most appropriate care, with or without chemotherapy or radiotherapy.
This surgery should nevertheless be conducted in awake condition to achieve two conflicting goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of functional structures. So awake after opening the skull, the patient undergoes a series of preoperative tests (motor, sensory and / or language), administered by a speech therapist present in the operating room. This procedure allows the neurosurgeon to establish an individual functional brain mapping in real time, through the observation by the SLP of the patient's answers to direct electrical stimulation applied to the cortical and sub-cortical. This support is based on the extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive lesion. To ensure the patient the highest achievable load should increase our understanding of brain function, including the neural bases of language, glioma grade 2 is predominantly localized functional area of language. Many studies apply to highlight the cortical organization of language, but the study of subcortical beams involved in this function, especially in the semantic language processing, has so far received less attention .
The use of electric direct intraoperative stimulation helps highlight the cortico-subcortical networks involved in language processing.
The new imaging techniques allow us to better understand the functional brain anatomy: the Diffusion Tensor can view the white matter bundles based on the diffusion of water molecules, functional MRI to visualize areas cortical functional.
- Conditions
- Oligoastrocytoma, Astrocytoma, Oligodendroglioma
- Being tested
- fMRI, tractography, neuropsychological examination
- Medical subject headings
- Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDevice
Patient with grade 2 glioma and healthy volunteers use a brain imaging (fMRI)
tractographyProcedure or surgery
Patient with grade 2 glioma and healthy volunteers use a brain imaging (tractography)
neuropsychological examinationOther
Patient with grade 2 glioma and healthy volunteers use a neuropsychological examination
| Study group | Role | What they receive |
|---|---|---|
| grade 2 glioma | Other | Patient with grade 2 glioma use a neuropsychological examination and brain imaging (fMRI and tractography) Receives: Device: fMRI; Procedure: tractography; Other: neuropsychological examination |
| healthy volunteers | Other | healthy volunteers use a neuropsychological examination and brain imaging (fMRI and tractography) Receives: Device: fMRI; Procedure: tractography; Other: neuropsychological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional score
The intraoperative testing is performed by an evaluator (speech / neuropsychologist), present in the operating room, the patient's side. Its role is to identify functional disturbances induced by direct electrical stimulation.
To do this, two standardized tests are administered to the patient alternately for the duration of the awake period. These tests are presented on a computer screen in PowerPoint format, with a picture every four seconds.
Measured: 1 day
Secondary outcomes (6)
Evaluation orthophonic
- Spontaneous Speech
- Test oral denomination: DO. 80 with computerized measurement of reaction time
- Verbal Fluence
- Categorical: animals
- Formal: letter / p /
- Test semantic matching: PPTT with computerized measurement of the reaction time
- trial test semantics / phonology
- Image Designation
Measured: 1 day
Evaluation orthophonic
- Spontaneous Speech
- Test oral denomination: DO. 80 with computerized measurement of reaction time
- Verbal Fluence
- Categorical: animals
- Formal: letter / p /
- Test semantic matching: PPTT with computerized measurement of the reaction time
- trial test semantics / phonology
- Image Designation
Measured: 5 day
Evaluation orthophonic
- Spontaneous Speech
- Test oral denomination: DO. 80 with computerized measurement of reaction time
- Verbal Fluence
- Categorical: animals
- Formal: letter / p /
- Test semantic matching: PPTT with computerized measurement of the reaction time
- trial test semantics / phonology
- Image Designation
Measured: 3 month
Imagery Data
Imagery Data
Measured: 1 day
Imagery Data
Imagery Data
Measured: 5 day
Imagery Data
Imagery Data
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2012
- Primary completionFeb 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligoastrocytomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903784
- Sponsor's protocol ID
- 8674
- Acronym
- BNL
- Status last verified
- May 2011
- First submitted
- 13 Sep 2016
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Basis of Language: A New Lighting. Study of Semantic Processing in MRI Mutimodale and Direct Electrical Stimulation
- ClinicalTrials.gov ID
- NCT02903784
- Acronym / sponsor ID
- BNL / 8674
- Conditions
- Oligoastrocytoma, Astrocytoma, Oligodendroglioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 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.
According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly progressive, infiltrating the central nervous system, mainly affecting young adults.
This surgery should nevertheless be conducted in awake condition to achieve two conflicting goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of functional structures. So awake after opening the skull, the patient undergoes a series of preoperative tests, administered by a speech therapist present in the operating room. This procedure allows the neurosurgeon to establish an individual functional brain mapping in real time, through the observation by the SLP of the patient's answers to direct electrical stimulation applied to the cortical and sub-cortical. This support is based on the extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive lesion. To ensure the patient the highest achievable load should increase our understanding of brain function, including the neural bases of language, glioma grade 2 is predominantly localized functional area of language.
Detailed description
According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly progressive, infiltrating the central nervous system, mainly affecting young adults. Surgical excision of the tumor is the most appropriate care, with or without chemotherapy or radiotherapy.
This surgery should nevertheless be conducted in awake condition to achieve two conflicting goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of functional structures. So awake after opening the skull, the patient undergoes a series of preoperative tests (motor, sensory and / or language), administered by a speech therapist present in the operating room. This procedure allows the neurosurgeon to establish an individual functional brain mapping in real time, through the observation by the SLP of the patient's answers to direct electrical stimulation applied to the cortical and sub-cortical. This support is based on the extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive lesion. To ensure the patient the highest achievable load should increase our understanding of brain function, including the neural bases of language, glioma grade 2 is predominantly localized functional area of language. Many studies apply to highlight the cortical organization of language, but the study of subcortical beams involved in this function, especially in the semantic language processing, has so far received less attention .
The use of electric direct intraoperative stimulation helps highlight the cortico-subcortical networks involved in language processing.
The new imaging techniques allow us to better understand the functional brain anatomy: the Diffusion Tensor can view the white matter bundles based on the diffusion of water molecules, functional MRI to visualize areas cortical functional.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| grade 2 glioma | Other | Device: fMRI, Procedure: tractography, Other: neuropsychological examinationPatient with grade 2 glioma use a neuropsychological examination and brain imaging (fMRI and tractography) |
| healthy volunteers | Other | Device: fMRI, Procedure: tractography, Other: neuropsychological examinationhealthy volunteers use a neuropsychological examination and brain imaging (fMRI and tractography) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients carry a grade glioma 2 functional area of language and presenting the information to receive surgical care provided in awake for the first time.
- or Healthy volunteers will be selected using a matching age and sex of patients in the study (matched to a patient on two of the first forty patients).
Key exclusion criteria (2 listed)
- Subject presenting cons-indications to MRI (ventricular shunt valve, ferromagnetic foreign bodies, pacemaker, implantable defibrillators, cochlear hearing implant, claustrophobia, ....)
- History of head trauma, ischemic stroke or intracerebral hematoma.
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 |
|---|---|---|
| fMRIPatient with grade 2 glioma and healthy volunteers use a brain imaging (fMRI) | Device | grade 2 glioma, healthy volunteers |
| tractographyPatient with grade 2 glioma and healthy volunteers use a brain imaging (tractography) | Procedure or surgery | grade 2 glioma, healthy volunteers |
| neuropsychological examinationPatient with grade 2 glioma and healthy volunteers use a neuropsychological examination | Other | grade 2 glioma, healthy volunteers |
Primary outcome
functional score
Time frame: 1 day
The intraoperative testing is performed by an evaluator (speech / neuropsychologist), present in the operating room, the patient's side. Its role is to identify functional disturbances induced by direct electrical stimulation. To do this, two standardized tests are administered to the patient alternately for the duration of the awake period. These tests are presented on a computer screen in PowerPoint format, with a picture every four seconds.
6 secondary outcomes
Evaluation orthophonic
Time frame: 1 day
Evaluation orthophonic
Time frame: 5 day
Evaluation orthophonic
Time frame: 3 month
Imagery Data
Time frame: 1 day
Imagery Data
Time frame: 5 day
Imagery Data
Time frame: 6 month
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 2 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI, tractography and neuropsychological examination in people with Oligoastrocytoma and Astrocytoma, run by University Hospital, Montpellier.
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 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: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
functional score (time frame: 1 day). 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 2 Sep 2020.