EpilepsyNCT01613911
Study of Human Sensory Perception
An observational study of Epilepsy, run by Swedish Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Epilepsy
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Swedish Medical Center Epilepsy Center
Seattle, Washington, 98122
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Invasive monitoring, Human sensory perception
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epileptics having invasive monitoring | People between 10 and 65 years of age with epilepsy and who are coming in to have invasive electrophysiological monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.
Secondary outcomes (1)
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.
Measured: Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613911
- Sponsor's protocol ID
- 5146S-11
- Status last verified
- Sep 2014
- First submitted
- 5 Jun 2012
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10450888Grill-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.
PubMed 10903579Hasson 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.
PubMed 11564319Hasson 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.
PubMed 15016991Kirsch 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.
PubMed 15145312Kleinman 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.
PubMed 17645542Kreiman 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.
PubMed 16446146Liu 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.
PubMed 16870724Logothetis 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.
PubMed 9854253Mukamel 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.
PubMed 16081741Niessing 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.
PubMed 16081740Nir 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.
PubMed 17686438Privman 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.
PubMed 17553996
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined fMRI and Electrophysiological Study of Human Sensory Perception
- ClinicalTrials.gov ID
- NCT01613911
- Acronym / sponsor ID
- 5146S-11
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Invasive monitoring, Human sensory perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epileptics having invasive monitoring | – | –People between 10 and 65 years of age with epilepsy and who are coming in to have invasive electrophysiological monitoring. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reveal induced neuronal activity
Time frame: Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.
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.
1 secondary outcome
Calculate evoked response potentials.
Time frame: Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Background: PubMed 10450888Allison 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.
- Background: PubMed 10903579Grill-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.
- Background: PubMed 11564319Hasson 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.
- Background: PubMed 15016991Hasson 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.
- Background: PubMed 15145312Kirsch 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.
- Background: PubMed 17645542Kleinman 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.
- Background: PubMed 16446146Kreiman 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.
- Background: PubMed 16870724Liu 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.
- Background: PubMed 9854253Logothetis 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.
- Background: PubMed 16081741Mukamel 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.
- Background: PubMed 16081740Niessing 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.
- Background: PubMed 17686438Nir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Swedish Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reveal induced neuronal activity (time frame: Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01613911, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.