Adult Brain TumorNCT04553341
Induction of Cortical Plasticity
A study testing Navigated repetitive transcranial magnetic stimulation in people with Adult Brain Tumor, run by Technical University of Munich at 1 site in Germany.
Trial summary
The study aims to induce plastic reorganization by a therapeutic protocol to increase the rate of gross total resection (GTR) and to optimize the oncological result. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult Brain Tumor
- What is being tested?
- Navigated repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 3 Oct 2020to Aug 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Intracerebral tumor
- Cortical function is located within planned resection area as confirmed by preoperative navigated transcranial magnetic stimulation and/or intraoperative direct electrical stimulation mapping
- Informed consent for participation
- Age >18 years
Who cannot join
- Prognosis less than 6 months
- Contraindications for MRI or nTMS (cardiac pacemaker, deep brain stimulator, cochlea implant
- Karnofsky-performance-index <60%
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurosurgery
Munich, Bavaria, 81675
Sandro M Krieg, MD, MBA, +49 89 4140 2151, sandro.krieg@tum.de
Sebastian Ille, MD, +49 89 4140 2151, sebastian.ille@tum.de
About this study
Official title: Induction of Cortical Plasticity by Navigated Transcranial Magnetic Stimulation
The study aims to induce plastic reorganization by a therapeutic protocol to increase the rate of gross total resection (GTR) and to optimize the oncological result.
Read the detailed description
Regarding the therapy of cerebral parenchyma tumors, the extent of resection (EOR) has a significant impact on the prognosis. However, total resection is not possible in up to 65% of cases because these tumors frequently infiltrate eloquent areas such as language or motor centers. Consequently, an optimal oncologic result from the surgical perspective cannot be achieved in a considerable large amount of patients. One possible solution is based on the tumor-induced shift of functional areas, which can move away from their original localization. Earlier studies already described the resection of glioma residuals during a second surgery after plastic reorganization has taken place. The authors complained that this reorganization is not detectable without surgery. Navigated transcranial magnetic stimulation (nTMS) was developed for the noninvasive localization of motor and language areas, which enables us to detect the spatial shift of cortical motor and language functions in tumor patients. Recent publications were already able to demonstrate that the individual and exact localization of the motor cortex leads to an increased EOR and prolongs the progression-free survival (PFS). Therefore, the current project intends to take advantage of this plastic reorganization for EOR optimization in cerebral parenchyma tumors. In this context, nTMS is supposed to also induce this plasticity within the frame of a repetitive stimulation protocol (rTMS). Besides other therapeutic applications, rTMS also showed a positive effect on the improvement of aphasia as well as motor recovery in patients after stroke, even in randomized multicenter studies, by inducing plastic reorganization. Moreover, rather than waiting for tumor-induced plastic reorganization, the investigators also aim to use the potential of rTMS for spatial plastic reorganization of functional areas adjacent to intracerebral parenchymal tumors to move functionally eloquent brain regions away from the planned resection cavity.
- Conditions
- Adult Brain Tumor
- Being tested
- Navigated repetitive transcranial magnetic stimulation
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigated repetitive transcranial magnetic stimulationDevice
In these patients we will apply the following protocol: after the initial nTMS mapping of the according function, patients will be stimulated on 20 consecutive days by a series of rTMS pulses. The frequencies (1-20 Hz), number of pulses (100-1,000), and stimulation intensities (50-130% resting motor threshold = rMT = individual lowest stimulation intensity that evokes positive muscle responses) will be applied in dependency of the individual patients comfort and the evoked effect. Stimulations will be applied to the eloquent brain region, which is infiltrated by the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Therepeutic | Experimental | rTMS Receives: Device: Navigated repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical location of function (nTMS)
Location of cortical motor or language function as measured by navigated transcranial magnetic stimulation (nTMS) mapping
Measured: 3 months
Secondary outcomes (5)
Cortical location of function (rsfMRI)
Location of cortical motor or language function as measured by resting state functional MRI (rsfMRI)
Measured: 3 months
Cortical location of function (DES)
Location of cortical motor or language function as measured by intraoperative direct electrical stimulation (DES)
Measured: 3 months
Cortical location of function (nTMS / rsfMRI / DES)
Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES
Measured: 6 months
Cortical location of function (nTMS / rsfMRI / DES)
Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES
Measured: 9 months
Cortical location of function (nTMS / rsfMRI / DES)
Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start3 Oct 2020
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Brain TumorStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro M. Krieg, Technical University of Munich
- Investigators
- Sandro M Krieg, MD, MBA, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553341
- Sponsor's protocol ID
- 404/18 S-AS
- Status last verified
- May 2023
- First submitted
- 27 Aug 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After confirmation by the local ethics committee, individual participant data that underlie the results reported in the manuscript will be available for investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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
- Induction of Cortical Plasticity by Navigated Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT04553341
- Acronym / sponsor ID
- 404/18 S-AS
- Conditions
- Adult Brain Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 3 Oct 2020 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 17 Sep 2020 (actual)
- 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.
The study aims to induce plastic reorganization by a therapeutic protocol to increase the rate of gross total resection (GTR) and to optimize the oncological result.
Detailed description
Regarding the therapy of cerebral parenchyma tumors, the extent of resection (EOR) has a significant impact on the prognosis. However, total resection is not possible in up to 65% of cases because these tumors frequently infiltrate eloquent areas such as language or motor centers. Consequently, an optimal oncologic result from the surgical perspective cannot be achieved in a considerable large amount of patients. One possible solution is based on the tumor-induced shift of functional areas, which can move away from their original localization. Earlier studies already described the resection of glioma residuals during a second surgery after plastic reorganization has taken place. The authors complained that this reorganization is not detectable without surgery. Navigated transcranial magnetic stimulation (nTMS) was developed for the noninvasive localization of motor and language areas, which enables us to detect the spatial shift of cortical motor and language functions in tumor patients. Recent publications were already able to demonstrate that the individual and exact localization of the motor cortex leads to an increased EOR and prolongs the progression-free survival (PFS). Therefore, the current project intends to take advantage of this plastic reorganization for EOR optimization in cerebral parenchyma tumors. In this context, nTMS is supposed to also induce this plasticity within the frame of a repetitive stimulation protocol (rTMS). Besides other therapeutic applications, rTMS also showed a positive effect on the improvement of aphasia as well as motor recovery in patients after stroke, even in randomized multicenter studies, by inducing plastic reorganization. Moreover, rather than waiting for tumor-induced plastic reorganization, the investigators also aim to use the potential of rTMS for spatial plastic reorganization of functional areas adjacent to intracerebral parenchymal tumors to move functionally eloquent brain regions away from the planned resection cavity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therepeutic | Experimental | Device: Navigated repetitive transcranial magnetic stimulationrTMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Intracerebral tumor
- Cortical function is located within planned resection area as confirmed by preoperative navigated transcranial magnetic stimulation and/or intraoperative direct electrical stimulation mapping
- Informed consent for participation
- Age >18 years
Key exclusion criteria (3 listed)
- Prognosis less than 6 months
- Contraindications for MRI or nTMS (cardiac pacemaker, deep brain stimulator, cochlea implant
- Karnofsky-performance-index <60%
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 |
|---|---|---|
| Navigated repetitive transcranial magnetic stimulationIn these patients we will apply the following protocol: after the initial nTMS mapping of the according function, patients will be stimulated on 20 consecutive days by a series of rTMS pulses. The frequencies (1-20 Hz), number of pulses (100-1,000), and stimulation intensities (50-130% resting motor threshold = rMT = individual lowest stimulation intensity that evokes positive muscle responses) will be applied in dependency of the individual patients comfort and the evoked effect. Stimulations will be applied to the eloquent brain region, which is infiltrated by the tumor. | Device | Therepeutic |
Primary outcome
Cortical location of function (nTMS)
Time frame: 3 months
Location of cortical motor or language function as measured by navigated transcranial magnetic stimulation (nTMS) mapping
5 secondary outcomes
Cortical location of function (rsfMRI)
Time frame: 3 months
Cortical location of function (DES)
Time frame: 3 months
Cortical location of function (nTMS / rsfMRI / DES)
Time frame: 6 months
Cortical location of function (nTMS / rsfMRI / DES)
Time frame: 9 months
Cortical location of function (nTMS / rsfMRI / DES)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: Yes. After confirmation by the local ethics committee, individual participant data that underlie the results reported in the manuscript will be available for investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Related trials for Adult Brain Tumor
Not yet recruitingObservational study
Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer
Brain Tumor Adult, Brain Metastases From Solid Tumors
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Tarlatamab for SCLC Brain Metastases
Small Cell Lung Cancer, Brain Metastases, Adult
RecruitingPhase 2
Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).
Diffuse Intrinsic Pontine Glioma, DIPG
Recruiting
Feasibility Assessment of Adapted Physical Activity in Patients Treated for a Brain Tumor
Brain Tumor Adult
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigated repetitive transcranial magnetic stimulation in people with Adult Brain Tumor, run by Technical University of Munich at 1 site in Germany.
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 3 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: status not confirmed, 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 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandro M Krieg, MD, MBA (+49 89 4140 2151, sandro.krieg@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical location of function (nTMS) (time frame: 3 months). 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; AzTrials last refreshed its copy on 30 Oct 2026.