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Brain Network Activation Analysis in Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03265925
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
ElMindA Ltd

Tracking Information
First Submitted Date August 20, 2017
First Posted Date August 29, 2017
Last Update Posted Date September 27, 2018
Actual Study Start Date May 26, 2017
Actual Primary Completion Date May 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2017)
Assess the BNA database for Epilepsy population and healthy controls. [ Time Frame: Epilepsy subjects will perform the BNA testing at baseline prior to change in medication if applicable and 3-10 days following change in medication when applicable. ]
Functional networks of brain activity in Epilepsy (Right and Left lobe) and healthy control individuals measured using analysis of EEG Event Related Potential (ERP) data. Clinical assessments battery will be utilized in order to examine different sets of BNA database for Epilepsy pathology and healthy controls.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03265925 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain Network Activation Analysis in Epilepsy
Official Title Brain Network Activation Analysis in Epilepsy
Brief Summary This is a prospective study investigating the utility of Brain Network Activation (BNA) analysis in patients with epilepsy.
Detailed Description

BNA technology is based on a network model to depict functional connectivity. The descriptive network model approach provides insights regarding inter-connectivity of brain networks and can describe the temporal-spatial brain activation patterns applied to various types of data-sets including EEG, MEG and fMRI.

In this study it is proposed that synchronization in brain activity may be disrupted in patients who experience frequent seizures and may correspond to functional impairments (e.g., memory, processing speed). As such, BNA analysis may provide additional data that complement current functional assessments, inform clinical assessment and management of epilepsy, and identify subgroups of patients that might be at risk for poor treatment outcomes.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be recruited from the long-term EEG monitoring floor and outpatient EEG laboratory. Controls will be recruited in response to advertisements. All participants will be given the BNA Auditory Go/NoGo task. Patient identity will be coded with a master record kept on a password protected computer in the laboratory. Deidentified data will be sent to ElMindA for scoring of the BNA test. Patient data from electronic medical records will be extracted along with patient MRI data processed.
Condition
  • Epilepsy
  • Epilepsy, Temporal Lobe
Intervention Not Provided
Study Groups/Cohorts
  • Epilepsy patients Right Temporal Lobe
    Epilepsy patients with seizures originating from the right temporal lobe
  • Epilepsy patients Left Temporal Lobe
    Epilepsy patients with seizures originating from the left temporal lobe
  • Healthy
    Healthy controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 26, 2018)
1
Original Estimated Enrollment
 (submitted: August 27, 2017)
90
Actual Study Completion Date May 8, 2018
Actual Primary Completion Date May 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants will be between ages 18-50 years old
  • Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments
  • Willingness to participate and able to give informed consent
  • If corrected vision: only Glasses should be used during the study testing

Exclusion Criteria:

  • History of significant head trauma
  • Evidence of other neurologic disease
  • Any diagnosed psychiatric or systemic condition that could lead to a change in brain activity or volume (e.g., stroke, Alzheimer's disease, alcoholism).
  • Currently with lice or open wounds on scalp
  • Significant sensory deficits
  • Use of a hearing aid that occupies the ear canal
  • Substance abuse in the last 3 months and any clinically significant substance dependency
  • Additional exclusion criteria for controls are a history of any neurological disease or psychological illness.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03265925
Other Study ID Numbers ELM-40
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ElMindA Ltd
Study Sponsor ElMindA Ltd
Collaborators Not Provided
Investigators
Principal Investigator: Travis Stoub, PhD
PRS Account ElMindA Ltd
Verification Date September 2018