Clinical trial NCT02590419: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Temporal Lobe Epilepsy
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
name: Synaptive Medical
First posted: 2015-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Total volume of tract damage
timeFrame: Assessed between pre and post-operative visits (6 month follow-up).
measure: Resection Zone
timeFrame: Assessed at surgical visit
measure: Post-operative visual field testing
timeFrame: Assessed at post-operative visit (6 month follow-up)
Secondary outcomes:
measure: Total neurological planning time
timeFrame: Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up).
measure: Total OR time
timeFrame: Assessed during surgical visit
measure: Duration of hospital stay
timeFrame: Assessed during surgical visit up to 26 weeks.
measure: Number of seizure free days
timeFrame: Assessed between surgical date until post-operative visit (6 month follow-up).
measure: Total cost of surgery
timeFrame: Assessed through study completion, an average of 1 year.
measure: Quality of life assessment
timeFrame: Assessed during surgical visit up to 26 weeks.
measure: Functional impairment
timeFrame: Assessed during surgical visit up to 26 weeks.
measure: Morbidity and complications
timeFrame: Assessed through study completion, an average of 1 year.
measure: Seizure control after surgery
timeFrame: Assessed at surgical visit up to 26 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences
name: Andrew Parrent
role: PRINCIPAL_INVESTIGATOR
References: