Electrodes Recognition Ability Clinical Trial
— LOC-ECOGOfficial title:
Efficient Automated Localization of ECoG Electrodes in CT Images Via Shape Analysis
| NCT number | NCT04479410 |
| Other study ID # | BIOING_01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 1, 2020 |
| Est. completion date | September 7, 2020 |
| Verified date | September 2020 |
| Source | Neuromed IRCCS |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
People with drug epilepsy (PwE) refractory to anti-seizure medications may be evaluated for
surgery. In several cases non invasive presurgical work-up is not sufficient for localization
of the Epileptogenic Zone and its correct delineation requires intracranial investigations by
means of intraparenchymal or subdural electrodes.The methodological approach with subdural
electrodes allows to obtain electrocorticography (ECoG) covering large cortical regions and
to map eloquent areas.
To delineate the seizure onset zone it is mandatory to precisely localize the electrode
position on the cortical surface. Electrodes are usually recognized by processing patients'
computed tomography (CT) images using simple image processing (e.g. thresholding) that
isolates metal objects. However, also wires, stitches, clips and other metal objects are
actually recognized and need to be removed by manual intervention. A new automated method,
based on shape analysis, will be retrospectively tested in a group of subjects with
refractory focal epilepsy previously investigated with subdural electrodes for diagnostic
purposes to provide advanced ECoG subdural electrodes recognition. A total of 24 CT scans
with a large number (> 1700) of round platinum electrodes arrays will be recruited for
testing.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | September 7, 2020 |
| Est. primary completion date | August 25, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients implanted with subdural ECoG electrodes underwent epilepsy surgery - Availability of a post-operative CT scan with acceptable image quality Exclusion Criteria: - Patients having CT scans with low image quality |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Irccs Neuromed | Pozzilli | IS |
| Lead Sponsor | Collaborator |
|---|---|
| Neuromed IRCCS | Federico II University |
Italy,
Arnulfo G, Narizzano M, Cardinale F, Fato MM, Palva JM. Automatic segmentation of deep intracerebral electrodes in computed tomography scans. BMC Bioinformatics. 2015 Mar 25;16:99. doi: 10.1186/s12859-015-0511-6. — View Citation
Branco MP, Gaglianese A, Glen DR, Hermes D, Saad ZS, Petridou N, Ramsey NF. ALICE: A tool for automatic localization of intra-cranial electrodes for clinical and high-density grids. J Neurosci Methods. 2018 May 1;301:43-51. doi: 10.1016/j.jneumeth.2017.10 — View Citation
Brunner P, Ritaccio AL, Lynch TM, Emrich JF, Wilson JA, Williams JC, Aarnoutse EJ, Ramsey NF, Leuthardt EC, Bischof H, Schalk G. A practical procedure for real-time functional mapping of eloquent cortex using electrocorticographic signals in humans. Epile — View Citation
Dykstra AR, Chan AM, Quinn BT, Zepeda R, Keller CJ, Cormier J, Madsen JR, Eskandar EN, Cash SS. Individualized localization and cortical surface-based registration of intracranial electrodes. Neuroimage. 2012 Feb 15;59(4):3563-70. doi: 10.1016/j.neuroimag — View Citation
Hermes D, Miller KJ, Noordmans HJ, Vansteensel MJ, Ramsey NF. Automated electrocorticographic electrode localization on individually rendered brain surfaces. J Neurosci Methods. 2010 Jan 15;185(2):293-8. doi: 10.1016/j.jneumeth.2009.10.005. Epub 2009 Oct — View Citation
Lachaux JP, Rudrauf D, Kahane P. Intracranial EEG and human brain mapping. J Physiol Paris. 2003 Jul-Nov;97(4-6):613-28. Review. — View Citation
Taimouri V, Akhondi-Asl A, Tomas-Fernandez X, Peters JM, Prabhu SP, Poduri A, Takeoka M, Loddenkemper T, Bergin AM, Harini C, Madsen JR, Warfield SK. Electrode localization for planning surgical resection of the epileptogenic zone in pediatric epilepsy. I — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Classification accuracy of a Linear Discriminant Analysis classifier in detecting electrodes | A distinct database will be created for each patient, with rows corresponding to potential electrode objects within the CT volume, and composed by a collection of the extracted geometrical features and the assigned class. Two classes will be considered: "electrode" and "non-electrode". The "electrode" class is assigned to the actual electrodes, while the non-electrode class is assigned to all the other detected metal objects. A Linear Discriminant Analysis (LDA) algorithm will be used for model training and data classification. Classification performances will be assessed by applying a 10-fold cross validation on each of the 24 patients' databases. In 10-fold cross-validation, the dataset will be randomly divided into 10 subsets of equal size, and then each subset will be tested using the classifier trained on the remaining nine subsets. Then, the obtained 10 classification accuracies will be averaged to provide an overall classification accuracy. |
September 2020 |