NCT02879682

Brief Summary

To compare presurgical motor mapping by navigated transcranial magnetic stimulation for surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data into neuronavigation as control. Primary objective: Permanently new postoperative deficit is lower when the preoperative motor mapping is available to the surgeon

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2016

Longer than P75 for phase_2

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

5.8 years

First QC Date

August 12, 2016

Last Update Submit

May 30, 2023

Conditions

GliomaBrain Metastases

Keywords

gliomabrain metastasesnTMS

Outcome Measures

Primary Outcomes (1)

  • Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale

    deterioration in NIHSS score

    3 months after surgery

Secondary Outcomes (8)

  • changed indication for surgery

    1 - 7 days before surgery

  • change of the approach

    1 - 7 days before surgery

  • size of craniotomy

    intraoperatively

  • use of intraoperative motor mapping via MEP

    intraoperatively

  • duration of intraoperative motor mapping via MEP

    intraoperatively

  • +3 more secondary outcomes

Study Arms (2)

nTMS

ACTIVE COMPARATOR

presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation

Procedure: nTMS data available for the surgeon

non-nTMS

SHAM COMPARATOR

presurgical motor mapping by nTMS without access of the surgeon to these data

Procedure: nTMS data not available for the surgeon

Interventions

nTMS data available for the surgeonPROCEDURE

the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon

nTMS
nTMS data not available for the surgeonPROCEDURE

the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon

non-nTMS

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indication for resection of a supratentorial tumor within or adjacent to the primary motor cortex
  • preoperative nTMS mapping of the ipsilateral hemisphere
  • implementation of the mapping data into preoperative planning
  • continuous MEP monitoring - informed consent

You may not qualify if:

  • no motor eloquent tumor
  • infratentorial tumor
  • no postoperative imaging
  • prognosis lower than 3 months of survival - age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Department of Neurosurgery, Klinikum rechts der Isar, TUM

Munich, Bavaria, 81675, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, Germany

Location

Vivantes Klinikum Neu-Kölln

Berlin, Germany

Location

Klinikum Bielefeld

Bielefeld, Germany

Location

Klinikum Günzburg

Günzburg, Germany

Location

Department of Neurosurgery, University of Messina

Messina, Italy

Location

Universität Bern

Bern, Switzerland

Location

MeSH Terms

Conditions

GliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sandro M Krieg, MD, MBA

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: preoperative Mapping
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 26, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2022

Study Completion

April 1, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)CH(1)DE(5)