Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery

October 28, 2015 updated by: Andrew Parrent
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.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
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.
EXPERIMENTAL: Treatment Arm
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.

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.

Other Names:
  • BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ Guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total volume of tract damage
Time Frame: Assessed between pre and post-operative visits (6 month follow-up).
Tract damage
Assessed between pre and post-operative visits (6 month follow-up).
Resection Zone
Time Frame: Assessed at surgical visit
Identification of resected region
Assessed at surgical visit
Post-operative visual field testing
Time Frame: Assessed at post-operative visit (6 month follow-up)
Outcome will be measured using a routine visual field testing procedure known as the Humphrey and Estermann perimetry test.
Assessed at post-operative visit (6 month follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total OR time
Time Frame: Assessed during surgical visit
Measured in hours
Assessed during surgical visit
Total neurological planning time
Time Frame: Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up).
Measured in hours
Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up).
Duration of hospital stay
Time Frame: Assessed during surgical visit up to 26 weeks.
Measured in # of days
Assessed during surgical visit up to 26 weeks.
Number of seizure free days
Time Frame: Assessed between surgical date until post-operative visit (6 month follow-up).
Measured in # of days
Assessed between surgical date until post-operative visit (6 month follow-up).
Total cost of surgery
Time Frame: Assessed through study completion, an average of 1 year.
Assessed through study completion, an average of 1 year.
Quality of life assessment
Time Frame: Assessed during surgical visit up to 26 weeks.
Measured using a standard epilepsy questionnaire known as the WHOQOL-BREF questionnaire (World Health Organization Quality of Life Assessment (WHOQOL-BREF))
Assessed during surgical visit up to 26 weeks.
Functional impairment
Time Frame: Assessed during surgical visit up to 26 weeks.
Measured using a routine functional impairment test known as the Karnofsky performance scale
Assessed during surgical visit up to 26 weeks.
Morbidity and complications
Time Frame: Assessed through study completion, an average of 1 year.
Number of cases
Assessed through study completion, an average of 1 year.
Seizure control after surgery
Time Frame: Assessed at surgical visit up to 26 weeks.
Assessed using a routine seizure control test known as the Engel score, assessed by a neurologist/epileptologist
Assessed at surgical visit up to 26 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Andrew Parrent, London Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ANTICIPATED)

November 1, 2016

Study Completion (ANTICIPATED)

November 1, 2016

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (ESTIMATE)

October 29, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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