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The sBE device is to be used 8 hours a day by the patients, during sleep, for 8 weeks, while also receiving standard chemotherapy Lomustine and Bevacizumab

Up to 12 associated unaffected partners may agree to sleep within the investigational sBE device congruent with the period of exposure of their rGBM partner (8 weeks + possible extension)

Home-based Static Magnetic and Electric (sBE) device that is slept in

Static Magnetic and Electric (sBE) device

Varun Monga, MD

A prospective, open label, single-center, early feasibility trial will be conducted to assess the safety and feasibility of a home-based Static Magnetic and Electric (sBE) device applied for 8 hours/day during sleep in adult participants with recurrent glioblastoma (rGBM) at their first relapse.

The purpose of this research study is to test the feasibility of a Static Magnetic and Electric Field (sBE) Device when combined with standard chemotherapy drugs, Lomustine and Bevacizumab, in the treatment of patients with recurrent glioblastoma.

The sBE device produces static magnetic (sB) and electric (sE) fields and is to be used 8 hours a day by the patients, during sleep, for 8 weeks, while also receiving standard chemotherapy Lomustine and Bevacizumab.

Patients will have visits in clinic every two weeks during the treatment period. The visits will include MRI scans, quality of life assessments, neurological and physical exams, and blood draws.

After the sBE treatment period, patients will continue standard chemotherapy with their regular oncologists.

Partners of the patients, who sleep in the same beds, will be invited to participate and will be involved in the study procedures except for those intended to monitor the disease. If partners do not agree to participate, they will not be able to sleep in the devices.

Cohort 1 - Main study group consisting of patients with rGBM and Cohort 2 - Substudy group consisting of a participating unaffected partners of patients with rGBM

Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma

Feasibility Study of a Static Magnetic and Electric Field Device in Adults With Recurrent Glioblastoma and Their Partners

sBE device use will be assessed based on participant compliance. Compliance will be assessed using sensors in the sBE device, self-reporting via a daily diary, and the sBE Device Questionnaire administered approximately every 2 weeks during the initial 8-week sBE administration period (to coincide with a cycle of lomustine or bevacizumab for Cohort 1 participants).

Safety of daily treatment with sBE as determined by the absence of Grade 3 adverse events attributable to sBE as outlined by the CTCAE v5.0

University of Iowa

Clinical Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma	NCT05410301	Glioblastoma Recurrent Gliob...	Static Magnetic... Lomustine Bevacizumab	18 Years -	University of Iowa
Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma	NCT05410301	Glioblastoma Recurrent Gliob...	Static Magnetic... Lomustine Bevacizumab	18 Years -	University of Iowa
Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma	NCT05410301	Glioblastoma Recurrent Gliob...	Static Magnetic... Lomustine Bevacizumab	18 Years -	University of Iowa

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