Optimization of Transcranial Motor Evoked Potentials in Supratentorial Surgeries

NCT06480370 | Recruiting

• 1 other identifier: 2024-D0039
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to optimize the methodology to elicite transcranial motor evoked potentials in intraoperative neurophysiological monitoring of brain surgery. It includes accelerometer measurements and microscope video image to determine movement of the surgical field, making possible minimization of movement during brain stimulation.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• threshold of stimulation and patient movement

  threshold of stimulation and patient movement quantified by an accelerometer placed on the forehead of the patient

  during surgery

Secondary Outcomes (3)

• patient movement

  during surgery

• subjective evaluation of magnitude of motion

  end of surgery

• quantification of magnitude

  end of surgery

Study Arms (1)

Study Arm

EXPERIMENTAL

Application of TES at different stimulation circuits, with different stimulation parameters and recording montages.

Device: ISIS IOM System

Interventions

ISIS IOM System DEVICE

Application of TES at different stimulation circuits, with different stimulation parameters and recording montages.

Study Arm

Eligibility Criteria

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

You may qualify if:

• Informed consent signed by the subject
• The patient has a supra-tentorial lesion requiring surgery
• The patient is undergoing neurosurgery with the use of MEP monitoring during surgery to protect functional tissue\* (During routine preparation for the surgery, patients are checked for any relative contraindications as listed in the user manual of the ISIS IOM System (see p. 11, chapter 2.2.4 of the user manual). Every relative contraindication must be weighed against the risk and benefits of the measurement signals which are routinely needed for the surgical intervention. There are no absolute contraindications for the ISIS IOM System.)
• The patient is older than 18 years

You may not qualify if:

• No need for MEP monitoring
• Vulnerable subjects (pregnant, impaired consciousness)
• People who do not want to participate in the study
• Emergency procedures in which no consent was obtained before the operation
• Multiple surgeries on the same patient
• Preoperative non-affected arm or leg motor deficit (MRC \<5), that is to say, no motor deficit of the arm or leg ipsilateral to the surgery
• Inhalational anesthesia
• Persisting neuromuscular blockade
• Impossibility to place the stimulating or recording electrodes in the appropriate site

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Neurosurgery, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

Related Publications (10)

• Holdefer RN, Skinner SA. Commentary : The value of intraoperative neurophysiological monitoring: evidence, equipoise and outcomes. J Clin Monit Comput. 2017 Aug;31(4):657-664. doi: 10.1007/s10877-016-9910-0. Epub 2016 Aug 1.

  PMID: 27481235 BACKGROUND

• Asimakidou E, Abut PA, Raabe A, Seidel K. Motor Evoked Potential Warning Criteria in Supratentorial Surgery: A Scoping Review. Cancers (Basel). 2021 Jun 4;13(11):2803. doi: 10.3390/cancers13112803.

  PMID: 34199853 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

• 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

• Dulfer SE, Gadella MC, Sahinovic MM, Lange F, Absalom AR, Groen RJM, Szelenyi A, Drost G. Stimulation parameters for motor evoked potentials during intraoperative spinal cord monitoring. A systematic review. Clin Neurophysiol. 2023 May;149:70-80. doi: 10.1016/j.clinph.2023.02.170. Epub 2023 Mar 4.

  PMID: 36924672 BACKGROUND

• Fujii M, Maesawa S, Motomura K, Futamura M, Hayashi Y, Koba I, Wakabayashi T. Intraoperative subcortical mapping of a language-associated deep frontal tract connecting the superior frontal gyrus to Broca's area in the dominant hemisphere of patients with glioma. J Neurosurg. 2015 Jun;122(6):1390-6. doi: 10.3171/2014.10.JNS14945. Epub 2015 Mar 27.

  PMID: 25816090 BACKGROUND

• Kapsalakis IZ, Kapsalaki EZ, Gotsis ED, Verganelakis D, Toulas P, Hadjigeorgiou G, Chung I, Fezoulidis I, Papadimitriou A, Robinson JS, Lee GP, Fountas KN. Preoperative evaluation with FMRI of patients with intracranial gliomas. Radiol Res Pract. 2012;2012:727810. doi: 10.1155/2012/727810. Epub 2012 Jul 12.

  PMID: 22848821 BACKGROUND

• Moiyadi A, Velayutham P, Shetty P, Seidel K, Janu A, Madhugiri V, Singh VK, Patil A, John R. Combined Motor Evoked Potential Monitoring and Subcortical Dynamic Mapping in Motor Eloquent Tumors Allows Safer and Extended Resections. World Neurosurg. 2018 Dec;120:e259-e268. doi: 10.1016/j.wneu.2018.08.046. Epub 2018 Aug 21.

  PMID: 30138733 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

• 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

Study Officials

• Seidel Kathleen, MD

  Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seidel Kathleen, MD

CONTACT

+41 31 632 57 88; kathleen.seidel@insel.ch

Pablo Abel Alvarez Abut, MD

CONTACT

pabloabel.alvarezabut@insel.ch

Study Design

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

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)