Induction of Cortical Plasticity

Adult Brain Tumor Clinical Trial

Official title:

Induction of Cortical Plasticity by Navigated Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04553341
• Other study ID #: 404/18 S-AS
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2020
• Est. completion date: August 2025

Study information

• Verified date: May 2023
• Source: Technical University of Munich
• Contact: Sandro M Krieg, MD, MBA
• Phone: +49 89 4140 2151
• Email: sandro.krieg[@]tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Adult Brain Tumor

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Neurosurgery	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical location of function (nTMS)	Location of cortical motor or language function as measured by navigated transcranial magnetic stimulation (nTMS) mapping	3 months
Secondary	Cortical location of function (rsfMRI)	Location of cortical motor or language function as measured by resting state functional MRI (rsfMRI)	3 months
Secondary	Cortical location of function (DES)	Location of cortical motor or language function as measured by intraoperative direct electrical stimulation (DES)	3 months
Secondary	Cortical location of function (nTMS / rsfMRI / DES)	Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES	6 months
Secondary	Cortical location of function (nTMS / rsfMRI / DES)	Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES	9 months
Secondary	Cortical location of function (nTMS / rsfMRI / DES)	Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES	12 months