Induction of Cortical Plasticity

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Brief Title

Induction of Cortical Plasticity

Official Title

Induction of Cortical Plasticity by Navigated Transcranial Magnetic Stimulation

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.
    


Study Type

Interventional


Primary Outcome

Cortical location of function (nTMS)

Secondary Outcome

 Cortical location of function (rsfMRI)

Condition

Adult Brain Tumor

Intervention

Navigated repetitive transcranial magnetic stimulation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

40

Start Date

October 2020

Completion Date

August 2025

Primary Completion Date

August 2024

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%
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sandro M Krieg, MD, MBA, +49 89 4140 2151, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04553341

Organization ID

404/18 S-AS


Responsible Party

Principal Investigator

Study Sponsor

Technische Universität München


Study Sponsor

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


Verification Date

September 2020