Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery

Temporal Lobe Epilepsy Clinical Trial

Official title:

Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02590419
• Other study ID #: UWO HSREB Ref#10317
• Status: Not yet recruiting
• Phase: N/A
• First received: July 8, 2015
• Last updated: October 28, 2015
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: October 2015
• Source: London Health Sciences Centre
• Contact: Andrew Parrent
• Phone: 519-663-3707
• Email: andrew.parrent[@]lhsc.on.ca
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe
• Temporal Lobe Epilepsy

Intervention

Device:
• BrightMatter™ products
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Andrew Parrent	Synaptive Medical, University of Western Ontario, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume of tract damage	Tract damage	Assessed between pre and post-operative visits (6 month follow-up).	No
Primary	Resection Zone	Identification of resected region	Assessed at surgical visit	No
Primary	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)	No
Secondary	Total neurological planning time	Measured in hours	Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up).	No
Secondary	Total OR time	Measured in hours	Assessed during surgical visit	No
Secondary	Duration of hospital stay	Measured in # of days	Assessed during surgical visit up to 26 weeks.	No
Secondary	Number of seizure free days	Measured in # of days	Assessed between surgical date until post-operative visit (6 month follow-up).	No
Secondary	Total cost of surgery		Assessed through study completion, an average of 1 year.	No
Secondary	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))	Assessed during surgical visit up to 26 weeks.	No
Secondary	Functional impairment	Measured using a routine functional impairment test known as the Karnofsky performance scale	Assessed during surgical visit up to 26 weeks.	No
Secondary	Morbidity and complications	Number of cases	Assessed through study completion, an average of 1 year.	No
Secondary	Seizure control after surgery	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.	No