Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial

Exclusion Criteria

• •1. The subject has a tumor in the brainstem, extensive or multicentric disease (e.g. in both hemispheres), or an abnormal regrowth pattern between the post operation MRI and RX planning MRI, suggesting early tumor progression, as determined by the Investigator's discretion.
• •2. The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, breastfeeding, incarcerated, or enrolled in another clinical investigation.
• •3. The subject has a severe acute infection, any autoimmune disease, significant congenital anomaly, other co-morbidity, or medical problem or is taking immunosuppressant therapy (except Dexamethasone) within 90 days of anticipated device use for a condition that in the opinion of the Investigator and Sponsor precludes enrollment in the investigation.
• •4. The subject has had a known focal or generalized seizure after surgery.
• •5. The subject has implants or any condition preventing the patient from undergoing serial MRI scans.
• •6. The patient has a skull defect (such as, missing bone with no replacement), bullet fragments or ferrous metals.
• •7. The subject has an active implanted device (e.g., cardiac pacemakers, Vagus Nerve Stimulation \[VNS\], Deep Brain Stimulation \[DBS\], programmable shunts, etc.).
• •8. The subject has any of the following lab results:
• •* ANC \< 1000 cells/mm3 or \< 1.5 x 10\^9 /L.
• •* Platelet count \< 100,000 cells/mm3.
• •9. The subject has a history of any previous anti-tumor treatment for a brain tumor.
• •10. The subject is currently being treated or has been treated with other investigational agents/devices that may compromise the results of this investigation (as per discretion of the Investigator).
• •11. The subject takes any nutritional supplements or alternative medical treatments that may compromise the results of this investigation (this is as per discretion of the Investigator, but any compound with anti-oxidant properties is strongly discouraged).
• •12. The subject has planned concomitant or adjuvant chemotherapy.