GliomaPhase 2/3MotorstimNCT02879682
nTMS for Motor Mapping of Rolandic Lesions
A Phase 2/3 study testing nTMS data available for the surgeon and nTMS data not available for the surgeon in people with Glioma and Brain Metastases, run by Technical University of Munich at 7 sites in 3 countries.
Trial summary
To compare presurgical motor mapping by navigated transcranial magnetic stimulation for surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data into neuronavigation as control. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Glioma, Brain Metastases
- What is being tested?
- nTMS data available for the surgeon and nTMS data not available for the surgeon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Aug 2016to Apr 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for resection of a supratentorial tumor within or adjacent to the primary motor cortex
- preoperative nTMS mapping of the ipsilateral hemisphere
- implementation of the mapping data into preoperative planning
- continuous MEP monitoring - informed consent
Who cannot join
- no motor eloquent tumor
- infratentorial tumor
- no postoperative imaging
- prognosis lower than 3 months of survival - age <18 years
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany5 sites
Charité Universitätsmedizin Berlin
Berlin
Vivantes Klinikum Neu-Kölln
Berlin
Klinikum Bielefeld
Bielefeld
Klinikum Günzburg
Günzburg
Department of Neurosurgery, Klinikum rechts der Isar, TUM
Munich, Bavaria, 81675
About this study
Official title: Randomized Controlled Multicenter Trial on the Impact of Presurgical Navigated Transcranial Magnetic Stimulation for Motor Mapping of Rolandic Lesions
To compare presurgical motor mapping by navigated transcranial magnetic stimulation for surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data into neuronavigation as control.
Primary objective: Permanently new postoperative deficit is lower when the preoperative motor mapping is available to the surgeon
Read the detailed description
Experimental intervention:
presurgical motor mapping by navigated transcranial magnetic stimulation and fusion with intraoperative neuronavigation
Control intervention:
presurgical motor mapping by navigated transcranial magnetic stimulation without access of the surgeon to this data Follow-up per patient: 6 months Duration of intervention per patient: 45 minutes
- Conditions
- Glioma, Brain Metastases
- Being tested
- nTMS data available for the surgeon, nTMS data not available for the surgeon
- Keywords
- glioma, brain metastases, nTMS
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nTMS data available for the surgeonProcedure or surgery
the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon
nTMS data not available for the surgeonProcedure or surgery
the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon
| Study group | Role | What they receive |
|---|---|---|
| nTMS | Active comparator | presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation Receives: Procedure: nTMS data available for the surgeon |
| non-nTMS | Sham comparator | presurgical motor mapping by nTMS without access of the surgeon to these data Receives: Procedure: nTMS data not available for the surgeon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale
deterioration in NIHSS score
Measured: 3 months after surgery
Secondary outcomes (8)
changed indication for surgery
towards surgery, avoids surgery towards biopsy, avoids surgery towards follow-up
Measured: 1 - 7 days before surgery
change of the approach
using a different direct to approach the lesion (different sulcus, gyrus, sub cortically)
Measured: 1 - 7 days before surgery
size of craniotomy
in mm ap and lateral
Measured: intraoperatively
use of intraoperative motor mapping via MEP
yes/no
Measured: intraoperatively
duration of intraoperative motor mapping via MEP
in min
Measured: intraoperatively
duration of surgery
in min
Measured: intraoperatively
extent of resection
in % via volumetry
Measured: intraoperatively
use of further modalities (fMRI, DTI fiber tracking, SSEP phase reversal)
yes/no
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2022
- Study completionApr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- preoperative Mapping
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Evangelisches Krankenhaus Bielefeld gGmbH
- Responsible party
- Sponsor
- Investigators
- Sandro M Krieg, MD, MBA, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879682
- Sponsor's protocol ID
- 5496/12
- Acronym
- Motorstim
- Status last verified
- May 2023
- First submitted
- 12 Aug 2016
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Multicenter Trial on the Impact of Presurgical Navigated Transcranial Magnetic Stimulation for Motor Mapping of Rolandic Lesions
- ClinicalTrials.gov ID
- NCT02879682
- Acronym / sponsor ID
- Motorstim / 5496/12
- Conditions
- Glioma, Brain Metastases
- Keywords
- glioma, brain metastases, nTMS
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Evangelisches Krankenhaus Bielefeld gGmbH
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare presurgical motor mapping by navigated transcranial magnetic stimulation for surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data into neuronavigation as control.
Primary objective: Permanently new postoperative deficit is lower when the preoperative motor mapping is available to the surgeon
Detailed description
Experimental intervention:
presurgical motor mapping by navigated transcranial magnetic stimulation and fusion with intraoperative neuronavigation
Control intervention:
presurgical motor mapping by navigated transcranial magnetic stimulation without access of the surgeon to this data Follow-up per patient: 6 months Duration of intervention per patient: 45 minutes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- preoperative Mapping
| Arm | Type | Receives |
|---|---|---|
| nTMS | Active comparator | Procedure: nTMS data available for the surgeonpresurgical motor mapping by nTMS and fusion with intraoperative neuronavigation |
| non-nTMS | Sham comparator | Procedure: nTMS data not available for the surgeonpresurgical motor mapping by nTMS without access of the surgeon to these data |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- indication for resection of a supratentorial tumor within or adjacent to the primary motor cortex
- preoperative nTMS mapping of the ipsilateral hemisphere
- implementation of the mapping data into preoperative planning
- continuous MEP monitoring - informed consent
Key exclusion criteria (4 listed)
- no motor eloquent tumor
- infratentorial tumor
- no postoperative imaging
- prognosis lower than 3 months of survival - age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nTMS data available for the surgeonthe preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon | Procedure or surgery | nTMS |
| nTMS data not available for the surgeonthe preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon | Procedure or surgery | non-nTMS |
Primary outcome
Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale
Time frame: 3 months after surgery
deterioration in NIHSS score
8 secondary outcomes
changed indication for surgery
Time frame: 1 - 7 days before surgery
change of the approach
Time frame: 1 - 7 days before surgery
size of craniotomy
Time frame: intraoperatively
use of intraoperative motor mapping via MEP
Time frame: intraoperatively
duration of intraoperative motor mapping via MEP
Time frame: intraoperatively
duration of surgery
Time frame: intraoperatively
extent of resection
Time frame: intraoperatively
use of further modalities (fMRI, DTI fiber tracking, SSEP phase reversal)
Time frame: intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandro M Krieg, MD, MBA principal investigator
Technical University of Munich
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing nTMS data available for the surgeon and nTMS data not available for the surgeon in people with Glioma and Brain Metastases, run by Technical University of Munich at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.