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Using technology called intraoperative monitoring (IOM) to monitor your brain during surgery

Intraoperative monitoring (IOM) versus no IOM during surgical resection of contrast enhancing motor eloquent tumors- two comparable prospective observational cohorts

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN95629670
Enrollment
50
Registered
2023-09-06
Start date
2023-09-15
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of motor function in patients having surgery with or without intraoperative monitoring for motor eloquent braintumours. Surgery

Interventions

Patients will undergo a clinical neurological examination prior to surgery which will include MCRS, NIHSS, six-spot-step test, 9-hole peg test, hand dynamometer, 10 timed walk test. Their surgery will

Sponsors

Odense University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Over the age of 18 years 2. Indication for resection of contrast enhancing lesion in MRI (HGG/GBM, MET) 3. Intention to reach either GTR or CRET 4. Motor eloquence defined as closer than 20mm to either the CST (measured in preoperative DTI) or to the precentral gyrus

Exclusion criteria

Exclusion criteria: 1. Vulnerable persons such as pregnant woman or children 2. Emergency cases 3. Tumors involving both hemispheres

Design outcomes

Primary

MeasureTime frame
1. Extent of resection (EOR) of contrast enhancing lesion (absolute and relative volume) on early postoperative MRI (24-48h) 2. Change in motor function (measured in MCRS, NIHSS, six-spot-step test, 9-hole peg test, hand dynamometer, 10 timed walk test, patients' global impression of change), 24 hours post op and 1 month post op.

Secondary

MeasureTime frame
1. Seizure history (change in Engel classification or antiepileptic drugs (AED)) after 1 month 2. Functional impairment measured using the Karnofsky performance scale at baseline and 1 month 3. Completeness of resection of fluorescein under the microscope judged by the surgeon at time of surgery 4. Surgeons impression on usefulness of intraoperative guidance at time of surgery

Countries

Denmark

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026