- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01613911
Study of Human Sensory Perception
4. desember 2014 oppdatert av: Swedish Medical Center
A Combined fMRI and Electrophysiological Study of Human Sensory Perception
This study will help describe how the human brain works when a person sees something, hears something, learns something, or thinks about something by recording brain activity that occurs when the person does a series of computer tasks.
This study will be offered to people who are in the hospital to be monitored for epilepsy by using electrodes placed in the brain.
The study will record brain activity that occurs when a patient does a memory task, for example.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Patients who have elected to have invasive electrophysiological monitoring for epileptic activity are invited to participate in this study.
While the electrodes are in place, patients are asked to view several scenarios on a laptop computer.
During these scenarios, for example, patients are asked to click a mouse button if they see the same picture twice in a row or to remember a film clip of a scooter ride.
Trigger points in the computer scenarios are recorded on a separate channel alongside the brain-wave activity to allow correlation between the brain activity and the task requested in the scenario.
Using this technique, researchers can determine what areas of the brain were active during recognition or recall activities.
Studietype
Observasjonsmessig
Registrering (Faktiske)
6
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Washington
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Seattle, Washington, Forente stater, 98122
- Swedish Medical Center Epilepsy Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
10 år til 65 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
People between 10 and 65 years old diagnosed with epilepsy who will have invasive eletrophysioloigcal monitoring as part of a clinical evaluation for epilepsy treatment.
Beskrivelse
Inclusion Criteria:
- Primary diagnosis of epilepsy
- Between 10 and 65 years of age
- Scheduled to undergo invasive electrophysiological monitoring as part of a clinical evaluation for epilepsy treatment
Exclusion Criteria:
- None
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Epileptics having invasive monitoring
People between 10 and 65 years of age with epilepsy and who are coming in to have invasive electrophysiological monitoring.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Reveal induced neuronal activity
Tidsramme: Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.
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In the preprocessing stage, potential electrical interference will be removed from the raw signal using a linear-phase notch FIR filter.
Each electrode will be de-referenced by subtraction of the averaged signal of all the electrodes, thus discarding non-neuronal contributions.
Time-frequency decompositions will be calculated for each electrode based on Fourier transform amplitude spectrum in a 160ms sliding window with average step size of 6ms.
This process is done per trial and averaged across trials in order to reveal induced neuronal activity, which is not time-locked to the stimuli.
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Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Calculate evoked response potentials.
Tidsramme: Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.
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Evoked response potentials (ERPs) will be calculated by averaging the raw signal across the presentation of a specific stimulus for each patient, such as all samples of patients watching the movie clip.
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Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Hasson U, Nir Y, Levy I, Fuhrmann G, Malach R. Intersubject synchronization of cortical activity during natural vision. Science. 2004 Mar 12;303(5664):1634-40. doi: 10.1126/science.1089506.
- Allison T, Puce A, Spencer DD, McCarthy G. Electrophysiological studies of human face perception. I: Potentials generated in occipitotemporal cortex by face and non-face stimuli. Cereb Cortex. 1999 Jul-Aug;9(5):415-30. doi: 10.1093/cercor/9.5.415.
- Grill-Spector K, Kushnir T, Hendler T, Malach R. The dynamics of object-selective activation correlate with recognition performance in humans. Nat Neurosci. 2000 Aug;3(8):837-43. doi: 10.1038/77754.
- Hasson U, Hendler T, Ben Bashat D, Malach R. Vase or face? A neural correlate of shape-selective grouping processes in the human brain. J Cogn Neurosci. 2001 Aug 15;13(6):744-53. doi: 10.1162/08989290152541412.
- Kirsch HE, Sepkuty JP, Crone NE. Multimodal functional mapping of sensorimotor cortex prior to resection of an epileptogenic perirolandic lesion. Epilepsy Behav. 2004 Jun;5(3):407-10. doi: 10.1016/j.yebeh.2004.02.001.
- Kleinman JT, Sepkuty JP, Hillis AE, Lenz FA, Heidler-Gary J, Gingis L, Crone NE. Spatial neglect during electrocortical stimulation mapping in the right hemisphere. Epilepsia. 2007 Dec;48(12):2365-8. doi: 10.1111/j.1528-1167.2007.01196.x. Epub 2007 Jul 21.
- Kreiman G, Hung CP, Kraskov A, Quiroga RQ, Poggio T, DiCarlo JJ. Object selectivity of local field potentials and spikes in the macaque inferior temporal cortex. Neuron. 2006 Feb 2;49(3):433-45. doi: 10.1016/j.neuron.2005.12.019.
- Liu J, Newsome WT. Local field potential in cortical area MT: stimulus tuning and behavioral correlations. J Neurosci. 2006 Jul 26;26(30):7779-90. doi: 10.1523/JNEUROSCI.5052-05.2006.
- Logothetis NK. Single units and conscious vision. Philos Trans R Soc Lond B Biol Sci. 1998 Nov 29;353(1377):1801-18. doi: 10.1098/rstb.1998.0333.
- Mukamel R, Gelbard H, Arieli A, Hasson U, Fried I, Malach R. Coupling between neuronal firing, field potentials, and FMRI in human auditory cortex. Science. 2005 Aug 5;309(5736):951-4. doi: 10.1126/science.1110913.
- Niessing J, Ebisch B, Schmidt KE, Niessing M, Singer W, Galuske RA. Hemodynamic signals correlate tightly with synchronized gamma oscillations. Science. 2005 Aug 5;309(5736):948-51. doi: 10.1126/science.1110948.
- Nir Y, Fisch L, Mukamel R, Gelbard-Sagiv H, Arieli A, Fried I, Malach R. Coupling between neuronal firing rate, gamma LFP, and BOLD fMRI is related to interneuronal correlations. Curr Biol. 2007 Aug 7;17(15):1275-85. doi: 10.1016/j.cub.2007.06.066.
- Privman E, Nir Y, Kramer U, Kipervasser S, Andelman F, Neufeld MY, Mukamel R, Yeshurun Y, Fried I, Malach R. Enhanced category tuning revealed by intracranial electroencephalograms in high-order human visual areas. J Neurosci. 2007 Jun 6;27(23):6234-42. doi: 10.1523/JNEUROSCI.4627-06.2007.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2012
Primær fullføring (Faktiske)
1. november 2014
Studiet fullført (Faktiske)
1. november 2014
Datoer for studieregistrering
Først innsendt
5. juni 2012
Først innsendt som oppfylte QC-kriteriene
6. juni 2012
Først lagt ut (Anslag)
7. juni 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. desember 2014
Sist bekreftet
1. september 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5146S-11
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .