Prognostic IntraOperative Biomarkers ideNtification in Tumor rElatEd suRgery
NCT ID: NCT06617208
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2025-12-01
2029-06-01
Brief Summary
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Aggressive brain tumors like glioma have the ability to infiltrate the surrounding healthy brain tissue, disrupting normal neuronal activities and leading to impaired motor and cognitive functions, as well as causing epilepsy. This malignant brain tumor is considered one of the most challenging cancers to treat, with a median survival of 12 to 15 months. Recent findings on direct neuron-tumor interactions indicate that abnormal brain activity in the regions surrounding brain tumors may contribute to develop epilepsy and accelerating tumor growth. Tumors tend to 'fuel' themselves with neurotransmitters released during its 'daily' neuronal firing. Hyperactive neurons in the peritumoral cortex can form excitatory electrochemical synapses with surrounding tumor cells, creating direct communication pathways within the peritumoral microenvironment, which aids in the progression and proliferation of tumor cells via direct and paracrine signalling pathways. However, the specific features of this abnormal brain activity in the peritumoral cortex have not been fully clarified and information on the pathological changes of neuronal activity in glioma patients is largely lacking. To advance more effective treatment strategies, it is crucial to better understand the complex interactions between the tumor and the brain.
This is especially important for the group of patients of which many perceive diminished quality of life because of epilepsy, cognitive functioning and language problems after tumor surgery. Furthermore, a thorough understanding is lacking of what tumor resection does to the original hyperactive peritumoral cortex and if resecting this is beneficial for improving postoperative outcome both for epilepsy as well as regarding survival. Therefore, identifying the hyperactive peritumoral cortex and directly addressing its impacts on the brain function and long-term surgical outcome could be a promising novel therapeutic strategy for treating glioma patients.
STUDY AIM
The measurement focuses on capturing neuronal activity at single-neuron resolution in the peritumoral cortex of glioma patients using cortical depth electrodes. It is well-established that gliomas can remodel the surrounding brain tissue, leading to abnormal neuronal hyperactivity, which contributes to tumor progression and epilepsy. However, the specific neuronal patterns and underlying mechanisms of these changes are not yet fully understood. This study will aim to collect detailed single-neuron recordings in this context, enabling us to map the precise neurophysiological disruptions caused by gliomas. On the long term, this research could lay the groundwork in identifying novel therapeutic approaches by providing critical in-sights into how gliomas alter brain function.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Neuropixel probe recording
Cortical electrophysiology using the Neuropixel probe is performed to record brain activity in the peritumoral cortex
Neuropixel probe recording
Neuropixel recordings captures neuronal activity at the single-neuron level across the layers of the cortex.
Interventions
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Neuropixel probe recording
Neuropixel recordings captures neuronal activity at the single-neuron level across the layers of the cortex.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible for surgery according to standard practices. If suitable and necessary according to standard practices, awake surgery is also permitted.
* Written Informed consent.
Exclusion Criteria
* Psychiatric history
* Previous brain tumour surgery or radiotherapy
* Severe aphasia or dysphasia
* Patient has pacemaker or other implanted electrical device such as vagal nerve stimulator or other
18 Years
90 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Koen van der Kuil
PhD Student
Principal Investigators
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Oscar Eelkman Rooda, MD PhD
Role: STUDY_DIRECTOR
Erasmus Medical Center
Central Contacts
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References
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Coughlin B, Munoz W, Kfir Y, Young MJ, Meszena D, Jamali M, Caprara I, Hardstone R, Khanna A, Mustroph ML, Trautmann EM, Windolf C, Varol E, Soper DJ, Stavisky SD, Welkenhuysen M, Dutta B, Shenoy KV, Hochberg LR, Mark Richardson R, Williams ZM, Cash SS, Paulk AC. Modified Neuropixels probes for recording human neurophysiology in the operating room. Nat Protoc. 2023 Oct;18(10):2927-2953. doi: 10.1038/s41596-023-00871-2. Epub 2023 Sep 11.
Paulk AC, Kfir Y, Khanna AR, Mustroph ML, Trautmann EM, Soper DJ, Stavisky SD, Welkenhuysen M, Dutta B, Shenoy KV, Hochberg LR, Richardson RM, Williams ZM, Cash SS. Large-scale neural recordings with single neuron resolution using Neuropixels probes in human cortex. Nat Neurosci. 2022 Feb;25(2):252-263. doi: 10.1038/s41593-021-00997-0. Epub 2022 Jan 31.
Chung JE, Sellers KK, Leonard MK, Gwilliams L, Xu D, Dougherty ME, Kharazia V, Metzger SL, Welkenhuysen M, Dutta B, Chang EF. High-density single-unit human cortical recordings using the Neuropixels probe. Neuron. 2022 Aug 3;110(15):2409-2421.e3. doi: 10.1016/j.neuron.2022.05.007. Epub 2022 Jun 8.
Leonard MK, Gwilliams L, Sellers KK, Chung JE, Xu D, Mischler G, Mesgarani N, Welkenhuysen M, Dutta B, Chang EF. Large-scale single-neuron speech sound encoding across the depth of human cortex. Nature. 2024 Feb;626(7999):593-602. doi: 10.1038/s41586-023-06839-2. Epub 2023 Dec 13.
Krishna S, Choudhury A, Keough MB, Seo K, Ni L, Kakaizada S, Lee A, Aabedi A, Popova G, Lipkin B, Cao C, Nava Gonzales C, Sudharshan R, Egladyous A, Almeida N, Zhang Y, Molinaro AM, Venkatesh HS, Daniel AGS, Shamardani K, Hyer J, Chang EF, Findlay A, Phillips JJ, Nagarajan S, Raleigh DR, Brang D, Monje M, Hervey-Jumper SL. Glioblastoma remodelling of human neural circuits decreases survival. Nature. 2023 May;617(7961):599-607. doi: 10.1038/s41586-023-06036-1. Epub 2023 May 3.
Venkataramani V, Yang Y, Schubert MC, Reyhan E, Tetzlaff SK, Wissmann N, Botz M, Soyka SJ, Beretta CA, Pramatarov RL, Fankhauser L, Garofano L, Freudenberg A, Wagner J, Tanev DI, Ratliff M, Xie R, Kessler T, Hoffmann DC, Hai L, Dorflinger Y, Hoppe S, Yabo YA, Golebiewska A, Niclou SP, Sahm F, Lasorella A, Slowik M, Doring L, Iavarone A, Wick W, Kuner T, Winkler F. Glioblastoma hijacks neuronal mechanisms for brain invasion. Cell. 2022 Aug 4;185(16):2899-2917.e31. doi: 10.1016/j.cell.2022.06.054. Epub 2022 Jul 31.
Venkataramani V, Tanev DI, Strahle C, Studier-Fischer A, Fankhauser L, Kessler T, Korber C, Kardorff M, Ratliff M, Xie R, Horstmann H, Messer M, Paik SP, Knabbe J, Sahm F, Kurz FT, Acikgoz AA, Herrmannsdorfer F, Agarwal A, Bergles DE, Chalmers A, Miletic H, Turcan S, Mawrin C, Hanggi D, Liu HK, Wick W, Winkler F, Kuner T. Glutamatergic synaptic input to glioma cells drives brain tumour progression. Nature. 2019 Sep;573(7775):532-538. doi: 10.1038/s41586-019-1564-x. Epub 2019 Sep 18.
Other Identifiers
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PaNaMa 12744
Identifier Type: -
Identifier Source: org_study_id
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