Using technology called intraoperative monitoring (IOM) to monitor your brain during surgery
| ISRCTN | ISRCTN95629670 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95629670 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 21/64369 |
| Sponsor | Odense University Hospital |
| Funder | Odense Universitetshospital |
- Submission date
- 31/08/2023
- Registration date
- 06/09/2023
- Last edited
- 25/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Neurosurgery for brain tumors has two main goals: removing as much of the tumor as possible to increase survival and preventing problems after surgery to enhance quality of life.
Currently, there isn't strong evidence from research studies that clearly shows whether using a technique called intraoperative neuromonitoring (IOM) is beneficial. We want to investigate if using IOM during surgery leads to better results for patients. We'll be looking at whether it helps protect their ability to move and also how much of the tumor can be taken out.
Who can participate?
People over the age of 18 years old who have a contrast-enhancing motor eloquent tumour. A "contrast-enhancing motor eloquent tumor" refers to a type of brain tumor that shows up really well in special pictures of the brain, thanks to a dye used during the scan. This dye makes the tumor stand out. The term "motor eloquent" means the tumor is in a spot of the brain that's responsible for controlling important body movements. So, if there's a tumor there, it could affect a person's ability to move properly. "Eloquent" in this case means this part of the brain does crucial things, like helping us move.
What does the study involve?
Surgery is performed with or without IOM and patients undergo clinical neurological examinations, before and after surgery (24 hours) and at follow-up (1 month)
What are the possible benefits and risks of participating?
As this is an observational study there are no extra risks or benefits in participating
Where is the study run from?
Odense University Hospital (Denmark)
When is the study starting and how long is it expected to run for?
May 2021 to March 2027
Who is funding the study?
Odense University Hospital (Denmark)
Who is the main contact?
Mette Schulz, mette.schulz@rsyd.dk
Mads Hjortdal Grønhøj, mads.groenhoej@rsyd.dk
Contact information
Scientific
J.B. Winsløwsvej 4
Odense C
5000
Denmark
 ORCID ID |
0000-0002-1473-9872 |
|---|---|
| Phone | +45 23252738 |
| mads.groenhoej@rsyd.dk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre prospective observational cohort study |
| Secondary study design | Cohort study |
| Participant information sheet | 44216 PIS.pdf |
| Scientific title | Intraoperative monitoring (IOM) versus no IOM during surgical resection of contrast enhancing motor eloquent tumors- two comparable prospective observational cohorts |
| Study objectives | To examine whether the use of IOM vs no IOM has an impact on the extent of resection (EOR) of contrast enhancing lesion (absolute and relative volume) on early postoperative MRI (24-72h) and to see if there is a difference in patientes' motor function after surgery. |
| Ethics approval(s) |
Approved 01/12/2021, Region Syddanmark (Damhaven 12, Vejle, 7100, Spain; +45 65412504; magnus.pedersen@rsyd.dk), ref: 21/64369 |
| Health condition(s) or problem(s) studied | Evaluation of motor function in patients having surgery with or without intraoperative monitoring for motor eloquent braintumours. |
| Intervention | 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 then be performed with ot without intraoperativ monitoring (IOM) based on availability of IOM. If IOM is used, subcortical mapping with a monopolar stimulation suction will be used to guide the surgeons with regards to proximity of corticospinal tracts and the lowest subcortical mapping threshold will be registered. 24 hours post op the patients will undergo the same clinical evaluation as described above. Patients will also recieve an MRI scan to evaloate extent of tumour resection. At one month follow-up the patients will again undergo the same neurological examination where Seizure history (change in Engel classification or antiepileptic drugs (AED)), change in Karnofsky performance scale and patients' global impression of change will also be avaluated. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Extent of resection (EOR) of contrast enhancing lesion (absolute and relative volume) on early postoperative MRI (24-48h) |
| Key secondary outcome measure(s) |
1. Seizure history (change in Engel classification or antiepileptic drugs (AED)) after 1 month |
| Completion date | 31/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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 |
| Key exclusion criteria | 1. Vulnerable persons such as pregnant woman or children 2. Emergency cases 3. Tumors involving both hemispheres |
| Date of first enrolment | 15/09/2023 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Odense C
5000
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be stored in a non-publicly available repository (REDCap - Open Patient data Explorative Network, https://www.open.rsyd.dk). Qualified researchers can request access to study data and a complete deidentified dataset will be made accessible, together with a data dictionary. Requests for access to the data can be made by sending an email together with a research plan to mads.groenhoej@rsyd.dk. Additional related documents will also be available upon request (eg. study protocol, statistical analysis plan, informed consent form). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/09/2023 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1 | 01/11/2021 | 04/09/2023 | No | No |
Additional files
- 44216 Protocol v1 01.11.2021.pdf
- Protocol file
- 44216 PIS.pdf
- Participant information sheet
Editorial Notes
25/11/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 15/11/2024 to 31/12/2026.
2. The overall study end date was changed from 15/12/2024 to 31/03/2027.
3. The intention to publish date was changed from 31/12/2025 to 31/03/2028.
11/09/2024: Study record confirmed as up to date.
04/09/2023: Trial's existence confirmed by Region Syddanmark
