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Induction of Cortical Plasticity

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ClinicalTrials.gov Identifier: NCT04553341
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Sandro M. Krieg, Technische Universität München

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553341


Contacts
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Contact: Sandro M Krieg, MD, MBA +49 89 4140 2151 sandro.krieg@tum.de
Contact: Sebastian Ille, MD +49 89 4140 2151 sebastian.ille@tum.de

Locations
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Germany
Department of Neurosurgery Recruiting
Munich, Bavaria, Germany, 81675
Contact: Sandro M Krieg, MD, MBA    +49 89 4140 2151    sandro.krieg@tum.de   
Contact: Sebastian Ille, MD    +49 89 4140 2151    sebastian.ille@tum.de   
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Sandro M Krieg, MD, MBA Technische Universität München
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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: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After confirmation by the local ethics committee, individual participant data that underlie the results reported in the manuscript will be available for investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Supporting Materials: Study Protocol
Time Frame: Data will be available after deidentification, beginning nine months and ending 36 months following article publication.
Access Criteria: Data will be available for individual participant data meta-analysis. Requestors will need to sign a data access agreement. Information regarding submitting proposals and accessing data will be published. Data will be made available by contacting the corresponding author of this manuscript via email.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No