JOURNAL ONKOLOGIE – STUDIE

Induction of Cortical Plasticity

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04553341

Studienbeginn:
Oktober 2020

Letztes Update:
01.06.2023

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technical University of Munich

Collaborator:
-

Studienleiter

Sandro M Krieg, MD, MBA
Principal Investigator
Technical University of Munich

Kontakt

Sandro M Krieg, MD, MBA
Kontakt:
Phone: +49 89 4140 2151
E-Mail: sandro.krieg@tum.de» Kontaktdaten anzeigen

Sebastian Ille, MD
Kontakt:
Phone: +49 89 4140 2151
E-Mail: sebastian.ille@tum.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Neurosurgery
81675 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Sandro M Krieg, MD, MBA
Phone: +49 89 4140 2151
E-Mail: sandro.krieg@tum.de

Sebastian Ille, MD
Phone: +49 89 4140 2151
E-Mail: sebastian.ille@tum.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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%

Studien-Rationale

Primary outcome:

1. 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

Secondary outcome:

1. Cortical location of function (rsfMRI) (Time Frame - 3 months):
Location of cortical motor or language function as measured by resting state functional MRI (rsfMRI)

2. Cortical location of function (DES) (Time Frame - 3 months):
Location of cortical motor or language function as measured by intraoperative direct electrical stimulation (DES)

3. 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

4. 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

5. 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

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov

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