Induction of Cortical Plasticity

Sponsor

Technische Universität München (Other)

Overall Status

Recruiting

CT.gov ID

NCT04553341

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adult Brain Tumor	Device: Navigated repetitive transcranial magnetic stimulation	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Outcome Measures

Primary Outcome Measures

Cortical location of function (nTMS) [3 months]
Location of cortical motor or language function as measured by navigated transcranial magnetic stimulation (nTMS) mapping

Secondary Outcome Measures

Cortical location of function (rsfMRI) [3 months]
Location of cortical motor or language function as measured by resting state functional MRI (rsfMRI)
Cortical location of function (DES) [3 months]
Location of cortical motor or language function as measured by intraoperative direct electrical stimulation (DES)
Cortical location of function (nTMS / rsfMRI / DES) [6 months]
Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES
Cortical location of function (nTMS / rsfMRI / DES) [9 months]
Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES
Cortical location of function (nTMS / rsfMRI / DES) [12 months]
Location of cortical motor or language function as measured by nTMS, rsfMRI, and /or DES

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurosurgery	Munich	Bavaria	Germany	81675

Sponsors and Collaborators

Technische Universität München

Investigators

Principal Investigator: Sandro M Krieg, MD, MBA, Technische Universität München

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 17, 2020

Last Update Posted:

Sep 17, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 17, 2020