Induction of Cortical Plasticity
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ClinicalTrials.gov Identifier: NCT04553341 |
Recruitment Status :
Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adult Brain Tumor | Device: Navigated repetitive transcranial magnetic stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Induction of Cortical Plasticity by Navigated Transcranial Magnetic Stimulation |
Estimated Study Start Date : | October 2020 |
Estimated Primary Completion Date : | August 2024 |
Estimated Study Completion Date : | August 2025 |

- Device: Navigated repetitive transcranial magnetic stimulation
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.
- 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
- Cortical location of function (rsfMRI) [ Time Frame: 3 months ]Location of cortical motor or language function as measured by resting state functional MRI (rsfMRI)
- Cortical location of function (DES) [ Time Frame: 3 months ]Location of cortical motor or language function as measured by intraoperative direct electrical stimulation (DES)
- Cortical location of function (nTMS / rsfMRI / DES) [ Time Frame: 6 months ]Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES
- Cortical location of function (nTMS / rsfMRI / DES) [ Time Frame: 9 months ]Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES
- Cortical location of function (nTMS / rsfMRI / DES) [ Time Frame: 12 months ]Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prognosis less than 6 months
- Contraindications for MRI or nTMS (cardiac pacemaker, deep brain stimulator, cochlea implant
- Karnofsky-performance-index <60%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553341
Contact: Sandro M Krieg, MD, MBA | +49 89 4140 2151 | sandro.krieg@tum.de | |
Contact: Sebastian Ille, MD | +49 89 4140 2151 | sebastian.ille@tum.de |
Germany | |
Department of Neurosurgery | Recruiting |
Munich, Bavaria, Germany, 81675 | |
Contact: Sandro M Krieg, MD, MBA +49 89 4140 2151 sandro.krieg@tum.de | |
Contact: Sebastian Ille, MD +49 89 4140 2151 sebastian.ille@tum.de |
Principal Investigator: | Sandro M Krieg, MD, MBA | Technische Universität München |
Responsible Party: | Sandro M. Krieg, apl. Prof. Dr. med. Sandro M. Krieg, MBA, Technische Universität München |
ClinicalTrials.gov Identifier: | NCT04553341 |
Other Study ID Numbers: |
404/18 S-AS |
First Posted: | September 17, 2020 Key Record Dates |
Last Update Posted: | September 17, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol |
Time Frame: | Data will be available after deidentification, beginning nine months and ending 36 months following article publication. |
Access Criteria: | Data will be available for individual participant data meta-analysis. Requestors will need to sign a data access agreement. Information regarding submitting proposals and accessing data will be published. Data will be made available by contacting the corresponding author of this manuscript via email. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |