- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02577757
Establishing the Language Network With Independent Component Analysis of Resting State MRI (ICA Langage)
Studieoversikt
Detaljert beskrivelse
Patients with brain tumors including malignant gliomas located in eloquent areas have long been considered inoperable because of median survival and predictable postoperative sequelae. The improved prognosis with chemoradiotherapy and surgical resection as complete as possible questioned this attitude. The goal is to operate those patients without additional disabilities. The cortical electrostimulation intraoperative mapping in awake surgery can meet the eloquent areas. Identifying with fMRI these same areas to better specify in advance the way initially and shortened the time to awake exploratory surgery which improves patient comfort. However anxiety induced by the review in a pre-operative setting, a debutante aphasia often make problematic the realization of a formal language test. The analysis in the low frequency of spontaneous oscillations of large neuronal networks can help isolate network of language at rest without particular language test at the group analysis. This methodology, however, needs to be validated at the individual level before it can be applied to pathology.
Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Angers, Frankrike, 49933
- Rekruttering
- Chu Angers
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Ta kontakt med:
- Aram TER MINASSIAN, Physician
- Telefonnummer: +33.2.41.35.52.31
- E-post: ArTerMinassian@chu-angers.fr
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Hovedetterforsker:
- Aram TER MINASSIAN
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Persons major and minor.
- Having given their written consent, or whose parents have given their written consent for minors.
- Affiliated with the social security system
- All patients eligible adults in awake surgery
- Affiliated with the social security system
- patient given their written consent
Exclusion Criteria
- Contraindications to MRI
- Pregnant or breastfeeding women
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: healthy volunteers
achieving functional MRI
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MR
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Eksperimentell: Eligible patients with awakened surgery
achieving functional MRI
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MR
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
MRI data obtained by comparing a formal language test to data obtained by a session of rest independent component analyzed in patients and volunteers
Tidsramme: 1 hour
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1 hour
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: ARAM TER MINASSIAN, MD, UH Angers
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CHU-Promoteur 2012-04
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