Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02474966
Status:
COMPLETED
Last Update Posted:
2015-06-18
First Post:
2015-06-11
Brief Title:
Effect of Deep TMS on the Permeability of the BBB in Patients With Glioblastoma Multiforme a Pilot Study
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Effects of Deep Transcranial Magnetic Stimulation on the Permeability of the Blood-brain Barrier in Patients With Glioblastoma Multiforme a Pilot Study
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The blood-brain barrier BBB is a specialized interface allowing a unique environment for neuro-glia networks BBB dysfunction is common in brain disorders The Transcranial Magnetic Stimulation TMS is a non-invasive method of stimulating cortical motor neurons with the use of rapidly changing electromagnetic fields generated by a coil placed over the scalp The objective of this study is to evaluate the safety and effects of the deep TMS dTMS on barrier integrity in patients with malignant glial tumors BBB permeability will be quantified using dynamic contrast-enhanced magnetic resonance imaging DCE-MRI Permeability change will be compared between two DCE-MRI scans performed immediately after real and sham rTMS randomly assigned within one week of each other
Detailed Description:
The blood-brain barrier BBB is a specialized interface allowing a unique environment for neuro-glia networks BBB dysfunction is common in brain disorders However the mechanisms underlying BBB opening are poorly understood The investigators suggest a novel mechanism modulating BBB integrity and therapeutic implications in patients with glioblastoma multiforme The Transcranial Magnetic Stimulation TMS is a noninvasive method of stimulating cortical motor neurons through the scalp and skull capable of inducing electrical currents and depolarizing neurons in focal brain areas with the use of rapidly changing electromagnetic fields generated by a coil placed over the scalp The objective of this study is to evaluate the safety and effects of the deep TMS dTMS on barrier integrity in 20 patients with malignant glial tumors glioblastoma multiforme BBB permeability will be quantified using dynamic contrast-enhanced magnetic resonance imaging DCE-MRI Permeability change will be compared between two DCE-MRI scans performed immediately after real and sham dTMS randomly assigned within one week of each other
Design of study Randomized double-blind crossover study Patients will present on two consecutive days in order to receive dTMS followed by DCE-MRI Subjects will be randomized into two groups the first group will be treated before with real-dTMS the first day and after with sham-dTMS the second day the second group will be treated before with sham-dTMS the first day and after with real-dTMS the second day At the end of each session of dTMS the patients will undergo by MRI exams
Enrolled patients twenty patients with glioblastoma multiforme treated with craniotomy and gross tumor resection or maximal debulking at least a year prior to the study and treated with standard post-operative radiotherapy and adjuvant chemotherapy
dTMS will be delivered at 1 Hz on the anterior periphery of the resected tumor bed using the Hesed-coil H-coil Brainsway Ltd Jerusalem Israel Sham stimulation will be delivered with a sham coil placed in the same helmet able to produce similar sounds and scalp sensations
Design of study Randomized double-blind crossover study Patients will present on two consecutive days in order to receive dTMS followed by DCE-MRI Subjects will be randomized into two groups the first group will be treated before with real-dTMS the first day and after with sham-dTMS the second day the second group will be treated before with sham-dTMS the first day and after with real-dTMS the second day At the end of each session of dTMS the patients will undergo by MRI exams
Enrolled patients twenty patients with glioblastoma multiforme treated with craniotomy and gross tumor resection or maximal debulking at least a year prior to the study and treated with standard post-operative radiotherapy and adjuvant chemotherapy
dTMS will be delivered at 1 Hz on the anterior periphery of the resected tumor bed using the Hesed-coil H-coil Brainsway Ltd Jerusalem Israel Sham stimulation will be delivered with a sham coil placed in the same helmet able to produce similar sounds and scalp sensations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None