- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02590419
Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrew Parrent
- Phone Number: 33707 519-663-3707
- Email: andrew.parrent@lhsc.on.ca
Study Contact Backup
- Name: Ali Khan
- Phone Number: 24280 519-931-5777
- Email: alir@robarts.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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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:
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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
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Assessed at surgical visit
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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.
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Assessed at post-operative visit (6 month follow-up)
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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).
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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).
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Measured in # of days
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Assessed between surgical date until post-operative visit (6 month follow-up).
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Total cost of surgery
Time Frame: Assessed through study completion, an average of 1 year.
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Assessed through study completion, an average of 1 year.
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Quality of life assessment
Time Frame: Assessed during surgical visit up to 26 weeks.
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Measured using a standard epilepsy questionnaire known as the WHOQOL-BREF questionnaire (World Health Organization Quality of Life Assessment (WHOQOL-BREF))
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Assessed during surgical visit up to 26 weeks.
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Functional impairment
Time Frame: Assessed during surgical visit up to 26 weeks.
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Measured using a routine functional impairment test known as the Karnofsky performance scale
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Assessed during surgical visit up to 26 weeks.
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Morbidity and complications
Time Frame: Assessed through study completion, an average of 1 year.
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Number of cases
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Assessed through study completion, an average of 1 year.
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Seizure control after surgery
Time Frame: Assessed at surgical visit up to 26 weeks.
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Assessed using a routine seizure control test known as the Engel score, assessed by a neurologist/epileptologist
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Assessed at surgical visit up to 26 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Parrent, London Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UWO HSREB Ref#10317
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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