Intraoperative Neurophysiological Monitoring in Brain Tumor Surgery: Prospective Cohort Studies

NCT07789938 | Not Yet Recruiting

• 1 other identifier: SDU-2025-176 - (3241)
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND Brain tumor surgery requires balancing two competing priorities: maximizing the extent of tumor resection to improve survival while preserving neurological function. This is particularly challenging in eloquent brain tumor surgery, where even minor injury may result in permanent loss of functions such as muscle paralysis, language impairment, or visual loss, substantially affecting patients' independence and quality of life. Intraoperative neurophysiological monitoring (IOM) combines functional mapping to identify eloquent structures with continuous monitoring of the integrity of eloquent structures during tumor resection. IOM with motor evoked potentials (MEP) is widely used to map and monitor motor-eloquent structurse but still lack high-quality evidence demonstrating patient-related benefit. Other modalities, including cortico-cortical evoked potentials (CCEP) for language monitoring and visual evoked potentials (VEP) for visual pathway monitoring, are promising but lack standardization and further clinical validation. AIM To strenghten the evidence base and clinical application of IOM in eloquent brain tumor surgery, enabling safer and more effective surgical treatment. HYPOTHESES The project is based on the following hypotheses:

1. 1.CCEP monitoring lacks standardization and clinical validation, and its use varies considerably across clinical practice.
2. 2.Intraoperative CCEP signal changes are associated with postoperative language impairment and can be used to establish clinically relevant warning thresholds.
3. 3.IOM with MEP improves motor function preservation and/or increases the extent of safe tumor resection compared with surgery without IOM.
4. 4.Intraoperative VEP signal changes are associated with postoperative visual impairment and can be used to establish clinically relevant warning thresholds.

Conditions

Malignant Brain Tumors; Visual Evoked Potential Monitoring; Motor Evoked Potential Monitoring; Cortico-cortical Evoked Potential Monitoring; Intraoperative Neurophysiological Monitoring

Keywords

IOM; intraoperative neurophysiological monitoring; motor evoked potential; cortico-cortical evoked potential; visual evoked potential; intraoperative monitoring; IOM in brain tumor surgery

Outcome Measures

Primary Outcomes (5)

• CCEP signal changes

  Changes in CCEP amplitudes of P1, N1, P2, N2 (μV and %) and peak latencies (ms and %), and stimulation threshold (mA and %) relative to baseline (BtW-asleep and BtW-awake)

  Intraoperative

• Postoperative language function

  Postoperative language function assessed using the DuLIP language test battery and Western Aphasia Battery at approximately 1 month, and again at 3 months in patients with speech impairment at at the 1-month follow-up. Significant speech impairment is defined as a deterioration of ≥ 2 points on the DuLIP language test battery and/or ≥ 5 points or a change in aphasia severity category on Western Aphasia Battery)

  At 1 month, and again at 3 months in patients with speech impairment at 1 month

• Postoperative motor function

  Postoperative motor function using the Medical Research Council scale during admission and at 1-month follow-up (0-5; 0-worse outcome, 5-better outcome).

  Postoperative Day 1, and at 1-month follow-up

• VEP signal changes

  Changes in VEP amplitudes of N1, P2 (P100), and N1-P2 peak-to-peak (μV and %) and latencies (ms and %) relative to baseline

  Intraoperative

• Postoperative visual function

  Postoperative visual function assessed using best-corrected visual acuity and perimetry. Significant postoperative visual impairment is defined as ≥2-line deterioration on the Snellen scale (total of 11 lines) and/or new or clinically relevant worsening of the visual field (mean deviation or pattern).

  At 1-2 weeks and 3 months

Secondary Outcomes (12)

• EOR

  Postoperative Day 1

• Karnofsky Performance Scale

  At 1-month follow-up

• National Institutes of Health Stroke Scale motor subscore

  During admission (Postoperative Day 1), and at 1-month follow-up

• Hand dynamometry

  Postoperative Day 1, and at 1-month follow-up

• 10-Meter Walk Test

  Postoperative Day 1, and at 1-month follow-up

Other Outcomes (2)

• Mortality

  At 1, 3, and 6 months

• Postoperative complications

  Within 1 month

Study Arms (2)

IOM with MEP

EXPERIMENTAL

Patients undergoing brain tumor surgery randomized to IOM with MEP

Diagnostic Test: Intraoperative neurophysiological monitoring

no IOM

ACTIVE COMPARATOR

Patients undergoing brain tumor surgery randomized to no IOM

Procedure: no Intraoperative neurophysiological monitoring

Interventions

no Intraoperative neurophysiological monitoring PROCEDURE

Part 3 is a randomized controlled trial which includes patients planned for resection of a motor eloquent brain tumor. Patients randomized to surgery with no intraoperative monitoring (IOM) will undergo surgery without IOM with motor evoked potentials (MEP).

no IOM

Intraoperative neurophysiological monitoring DIAGNOSTIC_TEST

The project includes three clinical studies: Part 2 is an observational cohort which includes patients planned for resection of a speech eloquent brain tumor. Intraoperative monitoring with cortico-cortical evoked potentials (CCEP) will be performed with the aim of exploring the relation of CCEP signal changes and postoperative speech impairment. Part 3 is a randomized controlled trial which includes patients planned for resection of a motor eloquent brain tumor. Patients randomized to surgery with intraoperative monitoring (IOM) will undergo surgery using IOM with motor evoked potentials (MEP). Part 4 is an observational cohort which includes patients planned for resection of a visual eloquent brain tumor. Intraoperative monitoring with visual evoked potentials (VEP) will be performed with the aim of exploring the relation of VEP signal changes and postoperative speech impairment.

Also known as: IOM

IOM with MEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age ≥ 18 years and ability to provide informed consent;
• Planned resection of ≥ 1 contrast-enhancing brain tumors (tentative diagnosis high-grade glioma or metastasis) on magnetic resonance imaging (MRI) in either general anesthesia or asleep-awake-asleep setting;
• Intended gross total or complete tumor resection;
• Tumor located \< 10 mm from the language areas (Broca's or Wernicke's) or subcortical language tracts (AF or SLF);
• Tumor located in a language-dominant hemisphere;
• Written informed consent.

You may not qualify if:

• Tumors directly involving Broca's or Wernicke's area;
• Pregnancy;
• Emergency surgery;
• Tumors involving both hemispheres.
• Patient age ≥ 18 years and ability to provide informed consent;
• Planned resection of ≥ 1 contrast enhancing brain tumors (tentative diagnosis high-grade glioma or metastasis) on MRI in general anesthesia setting;
• Intended gross total or complete tumor resection;
• Tumor located \< 20 mm from the precentral gyrus or CST;
• Written informed consent.
• Tumors directly involving the precentral gyrus or CST;
• Pregnancy;
• Emergency surgery;
• Recurrent brain tumor surgery;
• Tumors involving both hemispheres.
• Patient age ≥ 18 years and ability to provide informed consent;

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Neurosurgery, Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Related Publications (47)

• Duffau H, Velut S, Mitchell MC, Gatignol P, Capelle L. Intra-operative mapping of the subcortical visual pathways using direct electrical stimulations. Acta Neurochir (Wien). 2004 Mar;146(3):265-9; discussion 269-70. doi: 10.1007/s00701-003-0199-7. Epub 2004 Jan 8.

  PMID: 15015049 BACKGROUND

• Sato A, Ogiwara T, Sasaki T, Hongo K, Horiuchi T. How should visual function monitoring be performed and interpreted in surgery for suprasellar tumors? J Neurosurg. 2024 Apr 12;141(3):720-729. doi: 10.3171/2024.1.JNS232118. Print 2024 Sep 1.

  PMID: 38608298 BACKGROUND

• Sato A. Interpretation of the causes of instability of flash visual evoked potentials in intraoperative monitoring and proposal of a recording method for reliable functional monitoring of visual evoked potentials using a light-emitting device. J Neurosurg. 2016 Oct;125(4):888-897. doi: 10.3171/2015.10.JNS151228. Epub 2016 Feb 19.

  PMID: 26894463 BACKGROUND

• Houlden DA, Turgeon CA, Polis T, Sinclair J, Coupland S, Bourque P, Corsten M, Kassam A. Intraoperative flash VEPs are reproducible in the presence of low amplitude EEG. J Clin Monit Comput. 2014 Jun;28(3):275-85. doi: 10.1007/s10877-013-9532-8.

  PMID: 24233355 BACKGROUND

• Feng R, Schwartz J, Loewenstern J, Kohli K, Lenina S, Ultakan S, Iloreta AM, Govindaraj S, Bederson J, Banik R, Shrivastava R. The Predictive Role of Intraoperative Visual Evoked Potentials in Visual Improvement After Endoscopic Pituitary Tumor Resection in Large and Complex Tumors: Description and Validation of a Method. World Neurosurg. 2019 Jun;126:e136-e143. doi: 10.1016/j.wneu.2019.01.278. Epub 2019 Feb 19.

  PMID: 30794978 BACKGROUND

• Houlden DA, Turgeon CA, Amyot NS, Edem I, Sinclair J, Agbi C, Polis T, Alkherayf F. Intraoperative Flash Visual Evoked Potential Recording and Relationship to Visual Outcome. Can J Neurol Sci. 2019 May;46(3):295-302. doi: 10.1017/cjn.2019.4. Epub 2019 Mar 14.

  PMID: 30867080 BACKGROUND

• Boex C, Goga C, Berard N, Al Awadhi A, Bartoli A, Meling T, Bijlenga P, Schaller K. Intraoperative subcortico-cortical evoked potentials of the visual pathway under general anesthesia. Clin Neurophysiol. 2021 Jul;132(7):1381-1388. doi: 10.1016/j.clinph.2021.02.399. Epub 2021 Apr 9.

  PMID: 34023622 BACKGROUND

• Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C.

  PMID: 12719681 BACKGROUND

• Raabe A, Beck J, Schucht P, Seidel K. Continuous dynamic mapping of the corticospinal tract during surgery of motor eloquent brain tumors: evaluation of a new method. J Neurosurg. 2014 May;120(5):1015-24. doi: 10.3171/2014.1.JNS13909. Epub 2014 Mar 14.

  PMID: 24628613 BACKGROUND

• Gogos AJ, Young JS, Morshed RA, Avalos LN, Noss RS, Villanueva-Meyer JE, Hervey-Jumper SL, Berger MS. Triple motor mapping: transcranial, bipolar, and monopolar mapping for supratentorial glioma resection adjacent to motor pathways. J Neurosurg. 2020 Jun 5;134(6):1728-1737. doi: 10.3171/2020.3.JNS193434. Print 2021 Jun 1.

  PMID: 32502996 BACKGROUND

• Yeole U, Singh V, Mishra A, Shaikh S, Shetty P, Moiyadi A. Navigated intraoperative ultrasonography for brain tumors: a pictorial essay on the technique, its utility, and its benefits in neuro-oncology. Ultrasonography. 2020 Oct;39(4):394-406. doi: 10.14366/usg.20044. Epub 2020 Jun 17.

  PMID: 32660206 BACKGROUND

• Ambrosius WT, Mahnken JD. Power for studies with random group sizes. Stat Med. 2010 May 10;29(10):1137-44. doi: 10.1002/sim.3873.

  PMID: 20222151 BACKGROUND

• Kunieda T, Yamao Y, Kikuchi T, Matsumoto R. New Approach for Exploring Cerebral Functional Connectivity: Review of Cortico-cortical Evoked Potential. Neurol Med Chir (Tokyo). 2015;55(5):374-82. doi: 10.2176/nmc.ra.2014-0388. Epub 2015 Apr 28.

  PMID: 25925755 BACKGROUND

• De Witte E, Satoer D, Robert E, Colle H, Verheyen S, Visch-Brink E, Marien P. The Dutch Linguistic Intraoperative Protocol: a valid linguistic approach to awake brain surgery. Brain Lang. 2015 Jan;140:35-48. doi: 10.1016/j.bandl.2014.10.011. Epub 2014 Dec 17.

  PMID: 25526520 BACKGROUND

• Riva M, Fava E, Gallucci M, Comi A, Casarotti A, Alfiero T, Raneri FA, Pessina F, Bello L. Monopolar high-frequency language mapping: can it help in the surgical management of gliomas? A comparative clinical study. J Neurosurg. 2016 May;124(5):1479-89. doi: 10.3171/2015.4.JNS14333. Epub 2015 Sep 25.

  PMID: 26406788 BACKGROUND

• Tricco AC, Lillie E, Zarin W, O'Brien KK, Colquhoun H, Levac D, Moher D, Peters MDJ, Horsley T, Weeks L, Hempel S, Akl EA, Chang C, McGowan J, Stewart L, Hartling L, Aldcroft A, Wilson MG, Garritty C, Lewin S, Godfrey CM, Macdonald MT, Langlois EV, Soares-Weiser K, Moriarty J, Clifford T, Tuncalp O, Straus SE. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Ann Intern Med. 2018 Oct 2;169(7):467-473. doi: 10.7326/M18-0850. Epub 2018 Sep 4.

  PMID: 30178033 BACKGROUND

• Odom JV, Bach M, Brigell M, Holder GE, McCulloch DL, Mizota A, Tormene AP; International Society for Clinical Electrophysiology of Vision. ISCEV standard for clinical visual evoked potentials: (2016 update). Doc Ophthalmol. 2016 Aug;133(1):1-9. doi: 10.1007/s10633-016-9553-y. Epub 2016 Jul 21.

  PMID: 27443562 BACKGROUND

• Sharma R, Joshi S, Singh KD, Kumar A. Visual Evoked Potentials: Normative Values and Gender Differences. J Clin Diagn Res. 2015 Jul;9(7):CC12-5. doi: 10.7860/JCDR/2015/12764.6181. Epub 2015 Jul 1.

  PMID: 26393122 BACKGROUND

• Chung SB, Park CW, Seo DW, Kong DS, Park SK. Intraoperative visual evoked potential has no association with postoperative visual outcomes in transsphenoidal surgery. Acta Neurochir (Wien). 2012 Aug;154(8):1505-10. doi: 10.1007/s00701-012-1426-x. Epub 2012 Jun 29.

  PMID: 22739773 BACKGROUND

• Nishimura F, Wajima D, Park YS, Motoyama Y, Nakagawa I, Yamada S, Yokota H, Tamura K, Matsuda R, Takeshima Y, Takatani T, Nakase H. Efficacy of the visual evoked potential monitoring in endoscopic transnasal transsphenoidal surgery as a real-time visual function. Neurol India. 2018 Jul-Aug;66(4):1075-1080. doi: 10.4103/0028-3886.236963.

  PMID: 30038097 BACKGROUND

• Sasaki T, Itakura T, Suzuki K, Kasuya H, Munakata R, Muramatsu H, Ichikawa T, Sato T, Endo Y, Sakuma J, Matsumoto M. Intraoperative monitoring of visual evoked potential: introduction of a clinically useful method. J Neurosurg. 2010 Feb;112(2):273-84. doi: 10.3171/2008.9.JNS08451.

  PMID: 19199497 BACKGROUND

• Jashek-Ahmed F, Cabrilo I, Bal J, Sanders B, Grieve J, Dorward NL, Marcus HJ. Intraoperative monitoring of visual evoked potentials in patients undergoing transsphenoidal surgery for pituitary adenoma: a systematic review. BMC Neurol. 2021 Jul 23;21(1):287. doi: 10.1186/s12883-021-02315-4.

  PMID: 34301198 BACKGROUND

• Luo Y, Regli L, Bozinov O, Sarnthein J. Clinical utility and limitations of intraoperative monitoring of visual evoked potentials. PLoS One. 2015 Mar 24;10(3):e0120525. doi: 10.1371/journal.pone.0120525. eCollection 2015.

  PMID: 25803287 BACKGROUND

• Gutzwiller EM, Cabrilo I, Radovanovic I, Schaller K, Boex C. Intraoperative monitoring with visual evoked potentials for brain surgeries. J Neurosurg. 2018 Mar 30;130(2):654-660. doi: 10.3171/2017.8.JNS171168.

  PMID: 29600911 BACKGROUND

• Ota T, Kawai K, Kamada K, Kin T, Saito N. Intraoperative monitoring of cortically recorded visual response for posterior visual pathway. J Neurosurg. 2010 Feb;112(2):285-94. doi: 10.3171/2009.6.JNS081272.

  PMID: 19630493 BACKGROUND

• Rajashekar D, Lavrador JP, Ghimire P, Keeble H, Harris L, Pereira N, Patel S, Beyh A, Gullan R, Ashkan K, Bhangoo R, Vergani F. Simultaneous Motor and Visual Intraoperative Neuromonitoring in Asleep Parietal Lobe Surgery: Dual Strip Technique. J Pers Med. 2022 Sep 9;12(9):1478. doi: 10.3390/jpm12091478.

  PMID: 36143263 BACKGROUND

• Zauli FM, Revay M, Terzaghi M, Solbiati M, Cassani CM, Cossu M, d'Orio P, Castana L, Cardinale F, Mikulan E, Sartori I. Cortical and subcortical intraoperative-monitoring of the visual pathway under general anesthesia in epilepsy surgery. Clin Neurophysiol. 2024 Oct;166:96-107. doi: 10.1016/j.clinph.2024.07.011. Epub 2024 Jul 26.

  PMID: 39142121 BACKGROUND

• Shahar T, Korn A, Barkay G, Biron T, Hadanny A, Gazit T, Nossek E, Ekstein M, Kesler A, Ram Z. Elaborate mapping of the posterior visual pathway in awake craniotomy. J Neurosurg. 2018 May;128(5):1503-1511. doi: 10.3171/2017.2.JNS162757. Epub 2017 Aug 25.

  PMID: 28841121 BACKGROUND

• COPENHAVER RM, BEINHOCKER GD. EVOKED OCCIPITAL POTENTIALS RECORDED FROM SCALP ELECTRODES IN RESPONSE TO FOCAL VISUAL ILLUMINATION. Invest Ophthalmol. 1963 Aug;2:393-406. No abstract available.

  PMID: 14090730 BACKGROUND

• Olmsted ZT, Silverstein JW, Einstein EH, Sowulewski J, Nelson P, Boockvar JA, D'Amico RS. Evolution of flash visual evoked potentials to monitor visual pathway integrity during tumor resection: illustrative cases and literature review. Neurosurg Rev. 2023 Jan 30;46(1):46. doi: 10.1007/s10143-023-01955-z.

  PMID: 36715828 BACKGROUND

• Mariani V, Sartori I, Revay M, Mai R, Lizio D, Berta L, Rizzi M, Cossu M. Intraoperative Corticocortical Evoked Potentials for Language Monitoring in Epilepsy Surgery. World Neurosurg. 2021 Jul;151:e109-e121. doi: 10.1016/j.wneu.2021.03.141. Epub 2021 Apr 2.

  PMID: 33819704 BACKGROUND

• Yamao Y, Suzuki K, Kunieda T, Matsumoto R, Arakawa Y, Nakae T, Nishida S, Inano R, Shibata S, Shimotake A, Kikuchi T, Sawamoto N, Mikuni N, Ikeda A, Fukuyama H, Miyamoto S. Clinical impact of intraoperative CCEP monitoring in evaluating the dorsal language white matter pathway. Hum Brain Mapp. 2017 Apr;38(4):1977-1991. doi: 10.1002/hbm.23498. Epub 2017 Jan 23.

  PMID: 28112455 BACKGROUND

• Yamao Y, Matsumoto R, Kunieda T, Arakawa Y, Kobayashi K, Usami K, Shibata S, Kikuchi T, Sawamoto N, Mikuni N, Ikeda A, Fukuyama H, Miyamoto S. Intraoperative dorsal language network mapping by using single-pulse electrical stimulation. Hum Brain Mapp. 2014 Sep;35(9):4345-61. doi: 10.1002/hbm.22479. Epub 2014 Feb 24.

  PMID: 24615889 BACKGROUND

• Matsumoto R, Nair DR, LaPresto E, Najm I, Bingaman W, Shibasaki H, Luders HO. Functional connectivity in the human language system: a cortico-cortical evoked potential study. Brain. 2004 Oct;127(Pt 10):2316-30. doi: 10.1093/brain/awh246. Epub 2004 Jul 21.

  PMID: 15269116 BACKGROUND

• Suzuki Y, Enatsu R, Kanno A, Yokoyama R, Suzuki H, Tachibana S, Akiyama Y, Mikami T, Ochi S, Yamakage M, Mikuni N. The Influence of Anesthesia on Corticocortical Evoked Potential Monitoring Network Between Frontal and Temporoparietal Cortices. World Neurosurg. 2019 Mar;123:e685-e692. doi: 10.1016/j.wneu.2018.11.253. Epub 2018 Dec 18.

  PMID: 30576824 BACKGROUND

• Seidel K, Wermelinger J, Alvarez-Abut P, Deletis V, Raabe A, Zhang D, Schucht P. Cortico-cortical evoked potentials of language tracts in minimally invasive glioma surgery guided by Penfield stimulation. Clin Neurophysiol. 2024 May;161:256-267. doi: 10.1016/j.clinph.2023.12.136. Epub 2024 Mar 5.

  PMID: 38521679 BACKGROUND

• Titov O, Bykanov A, Pitskhelauri D, Danilov G. Neuromonitoring of the language pathways using cortico-cortical evoked potentials: a systematic review and meta-analysis. Neurosurg Rev. 2022 Jun;45(3):1883-1894. doi: 10.1007/s10143-021-01718-8. Epub 2022 Jan 15.

  PMID: 35031897 BACKGROUND

• Saito T, Tamura M, Muragaki Y, Maruyama T, Kubota Y, Fukuchi S, Nitta M, Chernov M, Okamoto S, Sugiyama K, Kurisu K, Sakai KL, Okada Y, Iseki H. Intraoperative cortico-cortical evoked potentials for the evaluation of language function during brain tumor resection: initial experience with 13 cases. J Neurosurg. 2014 Oct;121(4):827-38. doi: 10.3171/2014.4.JNS131195. Epub 2014 May 30.

  PMID: 24878290 BACKGROUND

• Chang EF, Clark A, Smith JS, Polley MY, Chang SM, Barbaro NM, Parsa AT, McDermott MW, Berger MS. Functional mapping-guided resection of low-grade gliomas in eloquent areas of the brain: improvement of long-term survival. Clinical article. J Neurosurg. 2011 Mar;114(3):566-73. doi: 10.3171/2010.6.JNS091246. Epub 2010 Jul 16.

  PMID: 20635853 BACKGROUND

• Seidel K, Beck J, Stieglitz L, Schucht P, Raabe A. Low-threshold monopolar motor mapping for resection of primary motor cortex tumors. Neurosurgery. 2012 Sep;71(1 Suppl Operative):104-14; discussion 114-5. doi: 10.1227/NEU.0b013e31824c02a0.

  PMID: 22270233 BACKGROUND

• Krieg SM, Shiban E, Droese D, Gempt J, Buchmann N, Pape H, Ryang YM, Meyer B, Ringel F. Predictive value and safety of intraoperative neurophysiological monitoring with motor evoked potentials in glioma surgery. Neurosurgery. 2012 May;70(5):1060-70; discussion 1070-1. doi: 10.1227/NEU.0b013e31823f5ade.

  PMID: 22067415 BACKGROUND

• Macdonald DB, Skinner S, Shils J, Yingling C; American Society of Neurophysiological Monitoring. Intraoperative motor evoked potential monitoring - a position statement by the American Society of Neurophysiological Monitoring. Clin Neurophysiol. 2013 Dec;124(12):2291-316. doi: 10.1016/j.clinph.2013.07.025. Epub 2013 Sep 18.

  PMID: 24055297 BACKGROUND

• Schucht P, Seidel K, Jilch A, Beck J, Raabe A. A review of monopolar motor mapping and a comprehensive guide to continuous dynamic motor mapping for resection of motor eloquent brain tumors. Neurochirurgie. 2017 Jun;63(3):175-180. doi: 10.1016/j.neuchi.2017.01.007. Epub 2017 May 13.

  PMID: 28506487 BACKGROUND

• Seidel K, Beck J, Stieglitz L, Schucht P, Raabe A. The warning-sign hierarchy between quantitative subcortical motor mapping and continuous motor evoked potential monitoring during resection of supratentorial brain tumors. J Neurosurg. 2013 Feb;118(2):287-96. doi: 10.3171/2012.10.JNS12895. Epub 2012 Nov 30.

  PMID: 23198802 BACKGROUND

• De Witt Hamer PC, Robles SG, Zwinderman AH, Duffau H, Berger MS. Impact of intraoperative stimulation brain mapping on glioma surgery outcome: a meta-analysis. J Clin Oncol. 2012 Jul 10;30(20):2559-65. doi: 10.1200/JCO.2011.38.4818. Epub 2012 Apr 23.

  PMID: 22529254 BACKGROUND

• Schucht P, Seidel K, Beck J, Murek M, Jilch A, Wiest R, Fung C, Raabe A. Intraoperative monopolar mapping during 5-ALA-guided resections of glioblastomas adjacent to motor eloquent areas: evaluation of resection rates and neurological outcome. Neurosurg Focus. 2014 Dec;37(6):E16. doi: 10.3171/2014.10.FOCUS14524.

  PMID: 25434385 BACKGROUND

• Al-Adli NN, Young JS, Sibih YE, Berger MS. Technical Aspects of Motor and Language Mapping in Glioma Patients. Cancers (Basel). 2023 Apr 6;15(7):2173. doi: 10.3390/cancers15072173.

  PMID: 37046834 BACKGROUND

MeSH Terms

Interventions

Intraoperative Neurophysiological Monitoring

Intervention Hierarchy (Ancestors)

Monitoring, Intraoperative; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Neurophysiological Monitoring; Surgical Procedures, Operative

Study Officials

• Mads H Grønhøj, Medical Doctor, PhD

  Department of Neurosurgery, Odense University Hospital

  STUDY DIRECTOR

• Frantz R Poulsen, Medical Doctor, PhD, Professor

  Department of Neurosurgery, Odense University Hospital

  STUDY CHAIR

Central Study Contacts

Einar T Björnsson, Medical Doctor

CONTACT

+45 50 65 80 79; einar.teitur.bjornsson@rsyd.dk

Mads H Grønhøj, Medical Doctor, PhD

CONTACT

+45 23 25 27 38; mads.groenhoej@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Part 1: Scoping review; Part 2: Observational cohort; Part 3: Randomized controlled trial; Part 4: Observational cohort.

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available through Zenodo open data repository after the end of project, which is planned at 31.12.2029, and for at least twenty years. Study Protocol, Statistical Analysis Plan, and Informed Consent Form will be available at project start on 01.01.2027 through publication of the protocol at the University of Southern Denmark's website, and through publication at clinicaltrials.gov., and will be kept public as long as possible.
• Access Criteria: All researchers will be able to access the IPD and supporting information, including the project's anonymised outcome measures.

Locations

DK (1)