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Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery

Primary Purpose

Temporal Lobe Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BrightMatter™ products
Sponsored by
Andrew Parrent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Temporal Lobe Epilepsy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with temporal lobe epilepsy between 18 and 65 years of age.
  • Patients whose seizures are disabling and/or are not controlled by any form of epileptic medication.
  • Patients whose clinical pre-surgical investigations indicates the need for anterior temporal lobe resection (ATLR).

Exclusion Criteria:

  • Prior resective epilepsy surgery.
  • Past or planned non resective epilepsy surgery (such as a corpus callosotomy and vagal nerve stimulator placement).
  • Contraindication to MRI, and/or whom are (or suspect to) being pregnant.
  • Complicated medical problems such as cancer or heart disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Group

    Treatment Arm

    Arm Description

    Control Group (involvement of BrightMatter™ Plan (BMP)): Patients with temporal lobe epilepsy, who have been identified as candidates for anterior temporal lobe resection (ATLR) will be recruited. All epilepsy patients will have clinical MRI scans that include a diffusion tensor imaging (DTI) protocol. Surgery will be carried out according to usual standard of care, without the use of processing for DTI tractography. Additional clinical scanning with the same protocol will be carried out post-operatively at 6 months. Pre-operative and post-operative (6-month) visual field assessments (Estermann Perimetry and Humphrey Perimetry) will also be carried out . Primary outcomes will be assessed to identify the baseline incidence of visual of postoperative visual field deficits.

    Treatment group (involvement of all three products BrightMatter™ Plan (BMP), BrightMatter™ Bridge (BMB), and BrightMatter™ Guide(BMG): A treatment group (prospective enrollment) that uses the interventional technology will be recruited based on the same eligibility criteria as control cohort. All epilepsy patients will have clinical MRI scans that include a DTI protocol. For this treatment group of patients, the BrightMatter system (BMB,BMP, and BMG) will be employed pre-operatively and intra-operatively for planning before and guidance during anterior temporal lobe resection (ATLR). Additional clinical scanning with the same protocol will be carried out post-operatively at 6 months. Pre-operative and post-operative (6-month) visual field assessments (Estermann Perimetry and Humphrey Perimetry) will also be carried out. Primary outcomes will be assessed to evaluate the effect of surgical planning and guidance with DTI tractography on outcomes, by comparison against the control cohort.

    Outcomes

    Primary Outcome Measures

    Total volume of tract damage
    Tract damage
    Resection Zone
    Identification of resected region
    Post-operative visual field testing
    Outcome will be measured using a routine visual field testing procedure known as the Humphrey and Estermann perimetry test.

    Secondary Outcome Measures

    Total neurological planning time
    Measured in hours
    Total OR time
    Measured in hours
    Duration of hospital stay
    Measured in # of days
    Number of seizure free days
    Measured in # of days
    Total cost of surgery
    Quality of life assessment
    Measured using a standard epilepsy questionnaire known as the WHOQOL-BREF questionnaire (World Health Organization Quality of Life Assessment (WHOQOL-BREF))
    Functional impairment
    Measured using a routine functional impairment test known as the Karnofsky performance scale
    Morbidity and complications
    Number of cases
    Seizure control after surgery
    Assessed using a routine seizure control test known as the Engel score, assessed by a neurologist/epileptologist

    Full Information

    First Posted
    July 8, 2015
    Last Updated
    October 28, 2015
    Sponsor
    Andrew Parrent
    Collaborators
    University of Western Ontario, Canada, Synaptive Medical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02590419
    Brief Title
    Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery
    Official Title
    Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    November 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Andrew Parrent
    Collaborators
    University of Western Ontario, Canada, Synaptive Medical

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Using Synaptive Medical's BrightMatter™ products to better visualize and plan epilepsy surgeries by considering white matter tracts, and considering whether the technology results in improved clinical outcomes.
    Detailed Description
    A common goal of focal brain resection is the removal of a lesion while preserving healthy eloquent tissues of the brain. One such eloquent area that is commonly aimed to be preserved are the white matter nerve fiber tracts which is critical of brain communication and function. This study aims to investigate whether the use of Synaptive Medical's BrightMatterTM technology can help neurosurgeons to better visualize and plan surgeries by considering the white matter tracts, and whether it results in improved clinical outcomes. This study will investigate the preservation of the optic radiations in anterior temporal lobectomy epilepsy surgeries.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporal Lobe Epilepsy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Control Group (involvement of BrightMatter™ Plan (BMP)): Patients with temporal lobe epilepsy, who have been identified as candidates for anterior temporal lobe resection (ATLR) will be recruited. All epilepsy patients will have clinical MRI scans that include a diffusion tensor imaging (DTI) protocol. Surgery will be carried out according to usual standard of care, without the use of processing for DTI tractography. Additional clinical scanning with the same protocol will be carried out post-operatively at 6 months. Pre-operative and post-operative (6-month) visual field assessments (Estermann Perimetry and Humphrey Perimetry) will also be carried out . Primary outcomes will be assessed to identify the baseline incidence of visual of postoperative visual field deficits.
    Arm Title
    Treatment Arm
    Arm Type
    Experimental
    Arm Description
    Treatment group (involvement of all three products BrightMatter™ Plan (BMP), BrightMatter™ Bridge (BMB), and BrightMatter™ Guide(BMG): A treatment group (prospective enrollment) that uses the interventional technology will be recruited based on the same eligibility criteria as control cohort. All epilepsy patients will have clinical MRI scans that include a DTI protocol. For this treatment group of patients, the BrightMatter system (BMB,BMP, and BMG) will be employed pre-operatively and intra-operatively for planning before and guidance during anterior temporal lobe resection (ATLR). Additional clinical scanning with the same protocol will be carried out post-operatively at 6 months. Pre-operative and post-operative (6-month) visual field assessments (Estermann Perimetry and Humphrey Perimetry) will also be carried out. Primary outcomes will be assessed to evaluate the effect of surgical planning and guidance with DTI tractography on outcomes, by comparison against the control cohort.
    Intervention Type
    Device
    Intervention Name(s)
    BrightMatter™ products
    Other Intervention Name(s)
    BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ Guide
    Intervention Description
    BrightMatter™ Plan (BMP): BMP is a software that enables surgeons to plan their neurosurgery preoperatively. BMP automatically generates whole brain tractography and highly accurate fusion of anatomical MRI and DTI images. BrightMatter™ Bridge (BMB):BMB involves offering SMI's MRI expertise to ensure a smooth workflow in neuroimaging including DTI to ensure optimized protocols are used to acquire the DTI images. Once the images are acquired, they are evaluated for their quality in real time using a quality control (QC) algorithm. The QC allows quality assessment of DTI images at the time-of-scan allowing for immediate correction while the patient is still there and reduces the need for patient re-scan. BrightMatter™ Guide (BMG): BMG is a neuro-navigation system that utilizes the DTI information and the trajectory planned by the surgeon in BMP pre-operatively, but bringing it into the operating room intraoperatively.
    Primary Outcome Measure Information:
    Title
    Total volume of tract damage
    Description
    Tract damage
    Time Frame
    Assessed between pre and post-operative visits (6 month follow-up).
    Title
    Resection Zone
    Description
    Identification of resected region
    Time Frame
    Assessed at surgical visit
    Title
    Post-operative visual field testing
    Description
    Outcome will be measured using a routine visual field testing procedure known as the Humphrey and Estermann perimetry test.
    Time Frame
    Assessed at post-operative visit (6 month follow-up)
    Secondary Outcome Measure Information:
    Title
    Total neurological planning time
    Description
    Measured in hours
    Time Frame
    Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up).
    Title
    Total OR time
    Description
    Measured in hours
    Time Frame
    Assessed during surgical visit
    Title
    Duration of hospital stay
    Description
    Measured in # of days
    Time Frame
    Assessed during surgical visit up to 26 weeks.
    Title
    Number of seizure free days
    Description
    Measured in # of days
    Time Frame
    Assessed between surgical date until post-operative visit (6 month follow-up).
    Title
    Total cost of surgery
    Time Frame
    Assessed through study completion, an average of 1 year.
    Title
    Quality of life assessment
    Description
    Measured using a standard epilepsy questionnaire known as the WHOQOL-BREF questionnaire (World Health Organization Quality of Life Assessment (WHOQOL-BREF))
    Time Frame
    Assessed during surgical visit up to 26 weeks.
    Title
    Functional impairment
    Description
    Measured using a routine functional impairment test known as the Karnofsky performance scale
    Time Frame
    Assessed during surgical visit up to 26 weeks.
    Title
    Morbidity and complications
    Description
    Number of cases
    Time Frame
    Assessed through study completion, an average of 1 year.
    Title
    Seizure control after surgery
    Description
    Assessed using a routine seizure control test known as the Engel score, assessed by a neurologist/epileptologist
    Time Frame
    Assessed at surgical visit up to 26 weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with temporal lobe epilepsy between 18 and 65 years of age. Patients whose seizures are disabling and/or are not controlled by any form of epileptic medication. Patients whose clinical pre-surgical investigations indicates the need for anterior temporal lobe resection (ATLR). Exclusion Criteria: Prior resective epilepsy surgery. Past or planned non resective epilepsy surgery (such as a corpus callosotomy and vagal nerve stimulator placement). Contraindication to MRI, and/or whom are (or suspect to) being pregnant. Complicated medical problems such as cancer or heart disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrew Parrent
    Phone
    519-663-3707
    Ext
    33707
    Email
    andrew.parrent@lhsc.on.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ali Khan
    Phone
    519-931-5777
    Ext
    24280
    Email
    alir@robarts.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew Parrent
    Organizational Affiliation
    London Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery

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