Brain Damage, Chronic, Cerebellar Cognitive Affective Syndrome, Cerebellar Mutism
Conditions
Brief summary
The goal of this project will be to demonstrate that Synaptive Medical's Diffusion Tensor Imaging(DTI) product functionality used in pre-operative planning and intraoperative surgical navigation, improves clinical outcomes corresponding to a reduction in neurological and neuropsychological deficits in pediatric brain tumor surgery.
Detailed description
Brain tumours are the most common form of solid tumours in children which often arise from the cerebellum. Treatment involves a complete resection of the tumour. Although surgical resection may eliminate most of the malignancy, signs of post-neurologic deficit may present as a consequence to the treatment. One such example is cerebellar mutism syndrome (CMS), a postoperative syndrome typically arising 1 to 2 days after resection of a midline posterior fossa tumor; it consists of diminished speech progressing to mutism, emotional lability, hypotonia, and ataxia. While some of the symptoms recover after a few months, neuropsychological testing shows long term deficits in language (agramatism), executive function and verbal memory. This study aims to investigate whether the use of Synaptive Medical's BrightMatter™ technology can help neurosurgeons better visualize and plan surgeries by avoiding eloquent fiber tracts in the brain and cerebellum; thus minimizing damage pertaining to neurologic and motor functionality. The use of these products will also be assessed for improved clinical outcomes in pediatric tumor surgery.
Interventions
DEVICEBrightMatter™ 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.
Sponsors
University of Western Ontario, Canada
Synaptive Medical
London Health Sciences Centre
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric subjects between the ages of 0-18 years with a brain tumor.
Exclusion criteria
* Pediatric subjects with contra-indication to MRI (metal, claustrophobia, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total volume of tract damage | Assess the total volume of tract damage from baseline pre-operative examination through study completion (~ 1 year). | Measure # of damaged tracts |
| Total size of craniotomy (resection zone) | Measure the total size of craniotomy from time of incision to end of surgery. (1 measurement/subject). | Measure craniotomy size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | Assessed during surgical visit up to 26 weeks | Measured in # of days |
| Total cost of surgery | Assessed through study completion, an average of 1 year | — |
| Total time it takes for the surgeon to pre-operatively plan cranial approach. | Assessed during start of surgical pre-operative plan through to end of surgical pre-operative plan (1 measurement/subject). | Measured in hours |
| Functional testing | Assessed during surgical visit up to 26 weeks | Measured using a routine functional impairment test for the pediatric population known as the Lansky performance scale |
| # deaths and complications with surgery | Assessed post-operatively after each surgery. Patient is followed until study completion (~ 1 year). | Number of cases |
| Quality of life assessment | Assessed during surgical visit up to 26 weeks | Measured using a standard questionnaire known as the WHOQOL-BREF questionnaire-World Health Organization Quality of Life Assessment |
| Total OR time | Assessed during surgical visit | Measured in hours |
Contacts
Primary ContactSandrine DeRibaupierre, MD
Backup ContactAli Khan, MD
Outcome results
None listed