Clinical trial · Interventional
Use of a Tonometer to Identify Epileptogenic Lesions During Pediatric Epilepsy Surgery
Use of a Tonometer to Identify Focal Cortical Dysplasia and Tuberous Sclerosis Complex During Pediatric Epilepsy Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We don't have funding to proceed with this study.
Summary
Brief summary (as posted)
Refractory epilepsy, meaning epilepsy that no longer responds to medication, is a common neurosurgical indication in children. In such cases, surgery is the treatment of choice. Complete resection of affected brain tissue is associated with highest probability of seizure freedom. However, epileptogenic brain tissue is visually identical to normal brain tissue, complicating complete resection. Modern investigative methods are of limited use. An important subjective assessment during surgery is that affected brain tissue feels stiffer, however there is presently no way to determine this without committing to resecting the affected area. It is hypothesized that intra-operative use of a tonometer (Diaton) will identify abnormal brain tissue stiffness in affected brain relative to normal brain. This will help identify stiffer brain regions without having to resect them. The objective is to determine if intra-operative use of a tonometer to measure brain tissue stiffness will offer additional precision in identifying epileptogenic lesions. In participants with refractory epilepsy, various locations on the cerebral cortex will be identified using standard pre-operative investigations like magnetic resonance imagin (MRI) and positron emission tomography (PET). These are areas of presumed normal and abnormal brain where the tonometer will be used during surgery to measure brain tissue stiffness. Brain tissue stiffness measurements will then be compared with results of routine pre-operative and intra-operative tests. Such comparisons will help determine if and to what extent intra-operative brain tissue stiffness measurements correlate with other tests and help identify epileptogenic brain tissue. 24 participants have already undergone intra-operative brain tonometry. Results in these participants are encouraging: abnormally high brain tissue stiffness measurements have consistently been identified and significantly associated with abnormal brain tissue. If the tonometer adequately identifies epileptogenic brain tissue through brain tissue stiffness measurements, it is possible that resection of identified tissue could lead to better post-operative outcomes, lowering seizure recurrences and neurological deficits.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epilepsy | — | UNRESOLVED | — |
| Focal Cortical Dysplasia | — | UNRESOLVED | — |
| Gliosis | — | UNRESOLVED | — |
| Hemimegalencephaly | — | UNRESOLVED | — |
| Polymicrogyria | — | UNRESOLVED | — |
| Rasmussen Encephalitis | — | UNRESOLVED | — |
| Stroke | — | UNRESOLVED | — |
| Sturge-Weber Syndrome | — | UNRESOLVED | — |
| Tuberous Sclerosis | — | UNRESOLVED | — |
| Tumor, Brain | Brain Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative brain tonometry | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brain tonometry
- description
- Participants undergoing intra-operative brain tissue stiffness measurements using a digital tonometer. Evaluated brain tissue is both presumed normal and abnormal based on results of pre-operative evaluations.
- interventionNames
- Device: Intra-operative brain tonometry
Primary outcomes (3)
- measure
- Brain tissue stiffness measurements in mmHg as assessed by intraoperative use of a digital tonometer on presumed normal cerebral cortex
- timeFrame
- Intraoperative
- description
- Brain tonometry is a novel diagnostic approach, therefore normal and abnormal brain tissue stiffness values are not known. Measurements will be taken on presumed normal cerebral cortex, based on results of preoperative evaluations (magnetic resonance imaging, electro-encephalography, positron emission tomography), to establish potential normal brain tissue stiffness values.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Participants with epilepsy who candidates for surgical treatment as established by a multidisciplinary committee specialized in epilepsy. * Participants undergoing resective surgery for epilepsy of dysplastic (examples: focal cortical dysplasia, tuberous sclerosis, hemimegalencephaly, polymicrogyria) or non-dysplastic etiology (examples: developmental tumors, gliosis, stroke, Rasmussen encephalitis, Sturge-Weber syndrome). Exclusion Criteria: * Lesion of interest located in a difficult to access region, such as paralimbic structures, insula, depth-of-sulci or inter-hemispheric.
References
Publications (16)
- BACKGROUNDGaitanis JN, Donahue J. Focal cortical dysplasia. Pediatr Neurol. 2013 Aug;49(2):79-87. doi: 10.1016/j.pediatrneurol.2012.12.024. PMID 23859852
- BACKGROUNDPalmini A, Holthausen H. Focal malformations of cortical development: a most relevant etiology of epilepsy in children. Handb Clin Neurol. 2013;111:549-65. doi: 10.1016/B978-0-444-52891-9.00058-0. PMID 23622203
- BACKGROUNDHarvey AS, Cross JH, Shinnar S, Mathern GW; ILAE Pediatric Epilepsy Surgery Survey Taskforce. Defining the spectrum of international practice in pediatric epilepsy surgery patients. Epilepsia. 2008 Jan;49(1):146-55. doi: 10.1111/j.1528-1167.2007.01421.x. Epub 2007 Nov 27. PMID 18042232
- BACKGROUNDWang ZI, Alexopoulos AV, Jones SE, Jaisani Z, Najm IM, Prayson RA. The pathology of magnetic-resonance-imaging-negative epilepsy. Mod Pathol. 2013 Aug;26(8):1051-8. doi: 10.1038/modpathol.2013.52. Epub 2013 Apr 5. PMID 23558575
- BACKGROUNDMellerio C, Labeyrie MA, Chassoux F, Daumas-Duport C, Landre E, Turak B, Roux FX, Meder JF, Devaux B, Oppenheim C. Optimizing MR imaging detection of type 2 focal cortical dysplasia: best criteria for clinical practice. AJNR Am J Neuroradiol. 2012 Nov;33(10):1932-8. doi: 10.3174/ajnr.A3081. Epub 2012 May 3. PMID 22555587
- BACKGROUNDPalmini A, Andermann F, Olivier A, Tampieri D, Robitaille Y. Focal neuronal migration disorders and intractable partial epilepsy: results of surgical treatment. Ann Neurol. 1991 Dec;30(6):750-7. doi: 10.1002/ana.410300603. PMID 1789692
- BACKGROUNDKrsek P, Maton B, Jayakar P, Dean P, Korman B, Rey G, Dunoyer C, Pacheco-Jacome E, Morrison G, Ragheb J, Vinters HV, Resnick T, Duchowny M. Incomplete resection of focal cortical dysplasia is the main predictor of poor postsurgical outcome. Neurology. 2009 Jan 20;72(3):217-23. doi: 10.1212/01.wnl.0000334365.22854.d3. Epub 2008 Nov 12.