Clinical trial · Interventional
Effect of Deep TMS on the Permeability of the BBB in Patients With Glioblastoma Multiforme: a Pilot Study
Effects of Deep Transcranial Magnetic Stimulation on the Permeability of the Blood-brain Barrier in Patients With Glioblastoma Multiforme: a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme of Brain | Brain Glioblastoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deep Transcranial Magnetic Stimulation (dTMS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Real-Sham dTMS
- description
- This arm will be treated before with real deep Transcranial Magnetic Stimulation (dTMS) (the first day) and after with sham dTMS (the second day)
- interventionNames
- Device: Deep Transcranial Magnetic Stimulation (dTMS)
- type
- EXPERIMENTAL
- label
- Sham-Real dTMS
- description
- This arm will be treated before with sham deep Transcranial Magnetic Stimulation (dTMS) (the first day) and after with real dTMS (the second day)
- interventionNames
- Device: Deep Transcranial Magnetic Stimulation (dTMS)
Primary outcomes (1)
- measure
- Change in blood-brain barrier permeability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of glioblastoma multiforme (WHO grade IV) * Craniotomy with resection of the tumor at least one year prior to the study * Treatment with steroids or chemotherapy stable for at least four weeks prior to study enrollment Exclusion Criteria: * History of epilepsy * Presence of cardiac pacemaker * Presence of neurostimulators * Presence of surgical clips or medical pumps * Allergy to contrast medium for Magnetic Resonance Imaging * History of head injuries * Alcoholism or drugs abuse * State of pregnant or breastfeeding * Severe psychiatric disorders
References
Publications (15)
- RESULTAbbott NJ, Patabendige AA, Dolman DE, Yusof SR, Begley DJ. Structure and function of the blood-brain barrier. Neurobiol Dis. 2010 Jan;37(1):13-25. doi: 10.1016/j.nbd.2009.07.030. Epub 2009 Aug 5. PMID 19664713
- RESULTBolwig TG, Hertz MM, Paulson OB, Spotoft H, Rafaelsen OJ. The permeability of the blood-brain barrier during electrically induced seizures in man. Eur J Clin Invest. 1977 Apr;7(2):87-93. doi: 10.1111/j.1365-2362.1977.tb01578.x. PMID 404164
- RESULTCote J, Bovenzi V, Savard M, Dubuc C, Fortier A, Neugebauer W, Tremblay L, Muller-Esterl W, Tsanaclis AM, Lepage M, Fortin D, Gobeil F Jr. Induction of selective blood-tumor barrier permeability and macromolecular transport by a biostable kinin B1 receptor agonist in a glioma rat model. PLoS One. 2012;7(5):e37485. doi: 10.1371/journal.pone.0037485. Epub 2012 May 21. PMID 22629405
- RESULTHirschberg H, Uzal FA, Chighvinadze D, Zhang MJ, Peng Q, Madsen SJ. Disruption of the blood-brain barrier following ALA-mediated photodynamic therapy. Lasers Surg Med. 2008 Oct;40(8):535-42. doi: 10.1002/lsm.20670. PMID 18798293
- RESULTPardridge WM. The blood-brain barrier: bottleneck in brain drug development. NeuroRx. 2005 Jan;2(1):3-14. doi: 10.1602/neurorx.2.1.3. PMID 15717053
- RESULTPrager O, Chassidim Y, Klein C, Levi H, Shelef I, Friedman A. Dynamic in vivo imaging of cerebral blood flow and blood-brain barrier permeability. Neuroimage. 2010 Jan 1;49(1):337-44. doi: 10.1016/j.neuroimage.2009.08.009. Epub 2009 Aug 12. PMID 19682584
- RESULTRossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.