Study of Human Sensory Perception

Epilepsy Clinical Trial

Official title:

A Combined fMRI and Electrophysiological Study of Human Sensory Perception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613911
• Other study ID #: 5146S-11
• Status: Completed
• Phase: N/A
• First received: June 5, 2012
• Last updated: December 4, 2014
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: September 2014
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	Swedish Medical Center Epilepsy Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Swedish Medical Center	Weizmann Institute of Science

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Jul 21. — View Citation

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. — View Citation

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. — View Citation

Logothetis NK. Single units and conscious vision. Philos Trans R Soc Lond B Biol Sci. 1998 Nov 29;353(1377):1801-18. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reveal induced neuronal activity	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.	Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.	No
Secondary	Calculate evoked response potentials.	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.	Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.	No