Temporal Lobe EpilepsyNCT02590419
Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery
A study testing BrightMatter™ products in people with Temporal Lobe Epilepsy, run by Andrew Parrent.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporal Lobe Epilepsy
- What is being tested?
- BrightMatter™ products
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Temporal Lobe Epilepsy
- Being tested
- BrightMatter™ products
- Medical subject headings
- Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrightMatter™ productsDevice
Also called BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ Guide
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BrightMatter™ products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of tract damage
Tract damage
Measured: Assessed between pre and post-operative visits (6 month follow-up).
Resection Zone
Identification of resected region
Measured: 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.
Measured: Assessed at post-operative visit (6 month follow-up)
Secondary outcomes (9)
Total neurological planning time
Measured in hours
Measured: Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up).
Total OR time
Measured in hours
Measured: Assessed during surgical visit
Duration of hospital stay
Measured in # of days
Measured: Assessed during surgical visit up to 26 weeks.
Number of seizure free days
Measured in # of days
Measured: Assessed between surgical date until post-operative visit (6 month follow-up).
Total cost of surgery
Measured: Assessed through study completion, an average of 1 year.
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))
Measured: Assessed during surgical visit up to 26 weeks.
Functional impairment
Measured using a routine functional impairment test known as the Karnofsky performance scale
Measured: Assessed during surgical visit up to 26 weeks.
Morbidity and complications
Number of cases
Measured: Assessed through study completion, an average of 1 year.
Seizure control after surgery
Assessed using a routine seizure control test known as the Engel score, assessed by a neurologist/epileptologist
Measured: Assessed at surgical visit up to 26 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporal Lobe EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Parrent
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, Synaptive Medical
- Responsible party
- Sponsor-investigator, Andrew Parrent, London Health Sciences Centre
- Investigators
- Andrew Parrent, Principal investigator, London Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590419
- Sponsor's protocol ID
- UWO HSREB Ref#10317
- Status last verified
- Oct 2015
- First submitted
- 8 Jul 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Diffusion Tensor Imaging and Tractography in Epilepsy Surgery
- ClinicalTrials.gov ID
- NCT02590419
- Acronym / sponsor ID
- UWO HSREB Ref#10317
- Conditions
- Temporal Lobe Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Andrew ParrentUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, Synaptive Medical
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: BrightMatter™ productsTreatment 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrightMatter™ productsAlso: BrightMatter™ Plan, BrightMatter™ Bridge, BrightMatter™ GuideBrightMatter™ 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. | Device | Treatment Arm |
Primary outcome
Total volume of tract damage
Time frame: Assessed between pre and post-operative visits (6 month follow-up).
Tract damage
Resection Zone
Time frame: Assessed at surgical visit
Identification of resected region
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.
9 secondary outcomes
Total neurological planning time
Time frame: Assessed during planning phase of surgery, between both pre and post-operative visits (6 month follow-up).
Total OR time
Time frame: Assessed during surgical visit
Duration of hospital stay
Time frame: 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).
Total cost of surgery
Time frame: Assessed through study completion, an average of 1 year.
Quality of life assessment
Time frame: Assessed during surgical visit up to 26 weeks.
Functional impairment
Time frame: Assessed during surgical visit up to 26 weeks.
Morbidity and complications
Time frame: Assessed through study completion, an average of 1 year.
Seizure control after surgery
Time frame: Assessed at surgical visit up to 26 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Parrent principal investigator
London Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing BrightMatter™ products in people with Temporal Lobe Epilepsy, run by Andrew Parrent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Parrent (519-663-3707 ext. 33707, andrew.parrent@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume of tract damage (time frame: Assessed between pre and post-operative visits (6 month follow-up).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015; AzTrials last refreshed its copy on 31 Oct 2026.