- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01613911
Study of Human Sensory Perception
December 4, 2014 updated by: 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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
6
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98122
- Swedish Medical Center Epilepsy Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reveal induced neuronal activity
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calculate evoked response potentials.
Time Frame: 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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
June 5, 2012
First Submitted That Met QC Criteria
June 6, 2012
First Posted (Estimate)
June 7, 2012
Study Record Updates
Last Update Posted (Estimate)
December 8, 2014
Last Update Submitted That Met QC Criteria
December 4, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5146S-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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