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Study of Human Sensory Perception

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Swedish Medical Center
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01613911
First received: June 5, 2012
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Combined fMRI and Electrophysiological Study of Human Sensory Perception

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • Reveal induced neuronal activity [ Time Frame: Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Calculate evoked response potentials. [ Time Frame: Approximately 3 hours over the course of 2-3 days during in-patient invasive electrophysiological monitoring. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Epileptics having invasive monitoring
People between 10 and 65 years of age with epilepsy and who are coming in to have invasive electrophysiological monitoring.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613911

Contacts
Contact: Becky Wood 206-320-7115 becky.wood@swedish.org
Contact: Colleen Ottinger 206-320-3695 colleen.ottinger@swedish.org

Locations
United States, Washington
Swedish Medical Center Epilepsy Center Recruiting
Seattle, Washington, United States, 98122
Contact: Becky Wood    206-320-7115    becky.wood@swedish.org   
Contact: Colleen Ottinger    206-320-3695    colleen.ottinger@swedish.org   
Principal Investigator: Jehuda Sepkuty, MD         
Sponsors and Collaborators
Swedish Medical Center
Weizmann Institute of Science
  More Information

Publications:

Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01613911     History of Changes
Other Study ID Numbers: 5146S-11
Study First Received: June 5, 2012
Last Updated: September 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Swedish Medical Center:
Epilepsy
Invasive monitoring
Human sensory perception

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 23, 2014