Induction of Cortical Plasticity

NCT ID: NCT04553341

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-03
• Study Completion Date: 2025-08-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therepeutic

rTMS

Group Type: EXPERIMENTAL

Navigated repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Sandro M. Krieg

apl. Prof. Dr. med. Sandro M. Krieg, MBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandro M Krieg, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Locations

Department of Neurosurgery

Munich, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sandro M Krieg, MD, MBA

Role: CONTACT

sandro.krieg@tum.de

+49 89 4140 2151

Sebastian Ille, MD

Role: CONTACT

sebastian.ille@tum.de

+49 89 4140 2151

Facility Contacts

Sandro M Krieg, MD, MBA

Role: primary

sandro.krieg@tum.de

+49 89 4140 2151

Sebastian Ille, MD

Role: backup

sebastian.ille@tum.de

+49 89 4140 2151

Other Identifiers

404/18 S-AS

Identifier Type: -

Identifier Source: org_study_id