- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01613911
Study of Human Sensory Perception
4. december 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
6
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Washington
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Seattle, Washington, Forenede Stater, 98122
- Swedish Medical Center Epilepsy Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
10 år til 65 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2012
Primær færdiggørelse (Faktiske)
1. november 2014
Studieafslutning (Faktiske)
1. november 2014
Datoer for studieregistrering
Først indsendt
5. juni 2012
Først indsendt, der opfyldte QC-kriterier
6. juni 2012
Først opslået (Skøn)
7. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. december 2014
Sidst verificeret
1. september 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 5146S-11
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .