Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery

NCT02590419 | Unknown

• 1 other identifier: UWO HSREB Ref#10317
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporal Lobe Epilepsy

Outcome Measures

Primary Outcomes (3)

• Total volume of tract damage

  Tract damage

  Assessed between pre and post-operative visits (6 month follow-up).

• Resection Zone

  Identification of resected region

  Assessed at surgical visit

• Post-operative visual field testing

  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 Outcomes (9)

• Total neurological planning time

  Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up).

• Total OR time

  Assessed during surgical visit

• Duration of hospital stay

  Assessed during surgical visit up to 26 weeks.

• Number of seizure free days

  Assessed between surgical date until post-operative visit (6 month follow-up).

• Total cost of surgery

  Assessed through study completion, an average of 1 year.

Study Arms (2)

Control Group

NO INTERVENTION

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 Arm

EXPERIMENTAL

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.

Device: BrightMatter™ products

Interventions

BrightMatter™ products DEVICE

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.

Also known as: BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ Guide

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrew Parrent: lead
• University of Western Ontario, Canada: collaborator
• Synaptive Medical: collaborator

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• Andrew Parrent

  London Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Parrent

CONTACT

519-663-3707; andrew.parrent@lhsc.on.ca

Ali Khan

CONTACT

519-931-5777; alir@robarts.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurosurgeon; Associate Professor

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: October 29, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 29, 2015

Record last verified: 2015-10