TMS Electrochemotherapy for Glioblastoma Multiforme - TMS Electrochemotherapy

Aarhus University Hospital0 个研究点目标入组 20 人开始时间: 2015年2月25日最近更新: 2018年2月19日

适应症

试验速览

暂无简介。

•1.Age 18 years or older
•2.Newly diagnosed and histologically confirmed GBM
•3.MGMT gene methylation
•4.If age < 70 years: Eligability for and ability to comply with the Stupp [4] chemo-radiotherapy regimen.
•5.If age > 70: Eligibility for stand alone chemotherapeutic treatment (without radiotherapy).
•6.Ability to comply with the proposed TMS treatment.
•7.Use of validated anti-conception for fertile female participants in concordance with guidelines provided by the Danish Health and Medicines Authority.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 13
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•1.Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy.
•2.Conditions that may contraindicate the use of transcranial magnetic stimulation (see Safety Summary for Cervel Neurotech Clinical rTMS Devices, and Cervel Neurotech rTMS System User Manual). Specifically this will include the represent of magnetic implants in the brain, uncontrollable symptomatic epilepsy refractory to standard medication, lack of ability to comply with TMS treatment.
•3. Implanted pacemaker or metal contraindicating the use of MRI-scan.
•4. Participation in clinical trials, which may by the investigators’ opinion interfere with or compromise treatment efficacy or safety or the interpretation and reliability of results.

发起方

Aarhus University Hospital