Induction of Cortical Plasticity

NCT04553341 | Unknown

• 1 other identifier: 404/18 S-AS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Cortical location of function (nTMS)

  Location of cortical motor or language function as measured by navigated transcranial magnetic stimulation (nTMS) mapping

  3 months

Secondary Outcomes (5)

• Cortical location of function (rsfMRI)

  3 months

• Cortical location of function (DES)

  3 months

• Cortical location of function (nTMS / rsfMRI / DES)

  6 months

• Cortical location of function (nTMS / rsfMRI / DES)

  9 months

• Cortical location of function (nTMS / rsfMRI / DES)

  12 months

Study Arms (1)

Therepeutic

EXPERIMENTAL

rTMS

Device: Navigated repetitive transcranial magnetic stimulation

Interventions

Navigated repetitive transcranial magnetic stimulation 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.

Therepeutic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prognosis less than 6 months
• Contraindications for MRI or nTMS (cardiac pacemaker, deep brain stimulator, cochlea implant
• Karnofsky-performance-index \<60%

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Neurosurgery

Munich, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sandro M Krieg, MD, MBA

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandro M Krieg, MD, MBA

CONTACT

+49 89 4140 2151; sandro.krieg@tum.de

Sebastian Ille, MD

CONTACT

+49 89 4140 2151; sebastian.ille@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: apl. Prof. Dr. med. Sandro M. Krieg, MBA

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 17, 2020
• Study Start: October 3, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

DE (1)