Validation of an Ex Vivo Calf Brain Force Detection System for Neurosurgical Simulation Training

NCT07583082 | Not Yet Recruiting

• 1 other identifier: 2018 4395
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Neurosurgery is a high-stakes surgical specialty where errors can result in significant patient mortality and morbidity. The amount of force applied on the brain simultaneously by the multiple different instruments during complex neurosurgical procedures is a critical safety metric that, to the investigators' knowledge, has not been previously measured in a realistic operative environment. The investigators have therefore developed a simulation platform integrating an ex vivo calf brain and a 3D-printed skull model attached to a force sensor capable of capturing real-time forces applied to the brain. A cross-sectional case series study will be conducted to evaluate the validity of the system. Medical students, neurosurgical residents, neurosurgical fellows, and staff neurosurgeons from four Quebec institutions will be recruited to perform three simulated subpial resections each using our ex vivo calf brain simulation platform. The forces applied by the microscissors, bipolar forceps, and ultrasonic aspirator onto the brain will be captured along with kinematic data. This study aims to establish the face, content, construct, and convergent validity of this ex vivo calf brain force detection system.

Conditions

Surgical Education

Keywords

Surgical Education; Surgical Simulation

Outcome Measures

Primary Outcomes (1)

• Forces applied to the brain during each simulated subpial resection procedure

  Throughout each simulated ex vivo subpial resection procedure, forces applied to the brain during tool-tissue contact will be measured by the force/torque sensor in grams and Newtons. This will enable for the assessment of differences in force applied by novice, intermediate, and expert participants.

  1 day of study

Secondary Outcomes (7)

• Face validity questionnaire responses

  1 day of study

• Content validity questionnaire responses

  1 day of study

• Objective Structured Assessment of Technical Skills (OSATS) scores for each simulated subpial resection procedure

  1 day of study

• Strength of emotions elicited

  1 day of study

• Levels of stress

  1 day of study

Interventions

Observational BEHAVIORAL

As such, no interventions are provided. All participants will perform three subpial resections on an ex vivo calf brain.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Staff neurosurgeons, neurosurgical fellows, neurosurgical residents, and medical students from four Quebec institutions.

You may not qualify if:

• For medical students, participation in a previous trial where they received training on the NeuroVR surgical simulator or the ex vivo calf brain simulation model.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Neuro Imaging and Surgical Technologies Lab, Montreal Neurological Institute and Hospital, McGill University

Montreal, Quebec, H3A 2B4, Canada

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Rolando F. Del Maestro, MD, PhD

  Neurosurgical Simulation and Artificial Intelligence Learning Centre, McGill University

  PRINCIPAL INVESTIGATOR

• Amir Hooshiar, PhD

  Surgical Performance Enhancement and Robotics Centre, McGill University

  STUDY DIRECTOR

• Houssem-Eddine Gueziri, PhD

  Laboratoire sur la science des données, Université TÉLUQ

  STUDY DIRECTOR

• D. Louis Collins, PhD

  Neuro Imaging and Surgical Technologies Lab, McGill University

  STUDY DIRECTOR

Central Study Contacts

Bianca Giglio, MSc

CONTACT

514-802-1608; bianca.giglio@mail.mcgill.ca

Mohammed Babgi, MD

CONTACT

mohammed.babgi@mail.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neurosurgical Simulation and Artificial Intelligence Learning Centre

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for 5 years following the completion of the trial.
• Access Criteria: Researchers who wish to access the data must contact the principal investigator of the trial, Dr. Rolando F. Del Maestro.

Locations

CA (1)