Magnetic and Electric Field Device for Glioblastoma

Overseen By Varun Monga, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Varun Monga, MD

Must be taking: Non-EIAED anti-convulsants

Must not be taking: EIAEDs, Anti-thrombotics

Disqualifiers: Implanted devices, Cardiac diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Static Magnetic and Electric (sBE) device, for individuals with recurrent glioblastoma, an aggressive brain cancer, to determine its safety and ease of use at home. The device applies magnetic and electric fields during sleep, alongside standard cancer treatments like lomustine and bevacizumab. Candidates include those who have experienced their first glioblastoma relapse and have previously undergone treatments such as temozolomide and radiation. Participants must use the device nightly for about eight hours and reside near Iowa City. Partners sharing a bed with participants can also join to help assess the device's safety. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking enzyme-inducing anti-epileptic drugs, you must switch to non-enzyme-inducing ones at least 2 weeks before starting the trial medications. It's best to discuss your specific medications with the trial team.

What prior data suggests that this Static Magnetic and Electric (sBE) device is safe for use in patients with recurrent glioblastoma?

Research shows that static magnetic and electric fields (sBE) are generally safe for people, but some important considerations remain. Studies have found that these fields can influence the body's redox system, which balances helpful and harmful molecules. This effect is noninvasive, meaning it doesn't involve surgery or entering the body.

Certain safety measures are necessary. For instance, people with metal implants or electronic devices inside their bodies need to be cautious, as the fields can cause metal objects to move, posing risks. Additionally, research involving magnetic fields, like those in MRI machines, suggests they might impact reaction time and memory in healthy individuals.

In this trial, the sBE device will be used during sleep, along with standard chemotherapy drugs. While additional safety information comes from the chemotherapy, the focus here is on the device. More research is needed to fully understand the long-term effects and safety of the sBE device, especially for people with specific health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the static magnetic and electric (sBE) device because it offers a unique way to tackle recurrent glioblastoma. Unlike standard treatments like surgery, radiation, or chemotherapy, which directly target tumor cells, the sBE device uses electromagnetic fields during sleep to potentially influence tumor behavior and enhance the effects of existing chemotherapy drugs like Lomustine and Bevacizumab. This device is non-invasive and could work synergistically with drugs to improve treatment outcomes without adding significant side effects. Additionally, the involvement of partners sleeping within the device's field opens new avenues for understanding environmental influences on treatment efficacy.

What evidence suggests that the Static Magnetic and Electric (sBE) device is effective for recurrent glioblastoma?

Studies have shown that magnetic fields can act like chemotherapy drugs, effectively targeting cancer cells. Research on similar devices, such as the Voyager, found no reports of worsening brain function in patients with recurring brain cancer after using the device. This trial examines the Static Magnetic and Electric (sBE) device, which combines magnetic and electric fields, alongside standard chemotherapy drugs Lomustine and Bevacizumab. This combination aims to enhance treatment effectiveness against brain cancer. Designed for use during sleep, the device offers a convenient option for patients. Additionally, unaffected partners sharing the bed may also use the sBE device during the trial period. ^{2 6 7 8 9}

Who Is on the Research Team?

Varun Monga, MD

Principal Investigator

University of Iowa Hospitals & Clinics

Are You a Good Fit for This Trial?

Inclusion Criteria

You must be able to use the sBE device on your own or with help from a caregiver.

Agree to allow the research team to assemble the sBE device in their homes and conduct in-person visits or video conference calls for technical support

You need to be able to read and sign a document that explains the study and your participation in it. The study will collect and use your blood and other tissues for research purposes, and you must agree to this.

Exclusion Criteria

You are currently pregnant or breastfeeding.

Definitive radiation therapy within three months before the diagnosis of disease progression

Hemorrhagic or thrombotic events within 6 months prior to study registration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the sBE device for 8 hours a day during sleep for 8 weeks, in combination with standard chemotherapy drugs Lomustine and Bevacizumab

8 weeks

4 visits (in-person)

Follow-up

Participants continue standard chemotherapy with their regular oncologists and are monitored for safety and effectiveness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Static Magnetic and Electric (sBE) device

How Is the Trial Designed?

Group I: Patients: sBE device applied during sleep, in combination with Lomustine and Bevacizumab Experimental Treatment 3 Interventions

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

Group II: Partners of Patients (who sleep in same bed): sBE Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

Varun Monga, MD

Lead Sponsor

Trials

7

Recruited

130+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Published Research Related to This Trial

A systematic review of 18 studies found that most dental instruments can be safely used on patients with cardiovascular implantable electronic devices (CIEDs), as the electromagnetic interference (EMI) effect is minimal at clinical distances.

In vitro studies showed potential EMI effects at close distances, but in vivo studies indicated that no significant interference with CIED function occurs during routine dental procedures, highlighting the importance of distance and device sensitivity settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic interference effect of dental equipment on cardiac implantable electrical devices: A systematic review. Niu, Y., Chen, Y., Li, W., et al.[2021]

Recent advancements in magnetic resonance (MR) technology have led to stronger magnetic fields and improved safety features, but most MR-related injuries and fatalities are due to non-compliance with safety guidelines.

To enhance safety in MR environments, it is crucial to update and revise safety information regarding biological effects and the compatibility of biomedical implants and devices with current MR technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR procedures: biologic effects, safety, and patient care. Shellock, FG., Crues, JV.[2008]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05410301

Golden Halo, Static Magnetic and Electric Field Device, in ... 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 ...

2. withpower.com withpower.com/trial/phase-recurrent-glioblastoma-7-2022-6be38

Golden Halo, Static Magnetic and Electric Field Device, in ... This trial tests a new device that creates magnetic and electric fields, used while patients sleep. It targets adults whose brain cancer has returned after ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12237630/

Potential mechanisms and clinical applications of static ... A study on recurrent glioblastoma patients using the Voyager device showed no reports of neurofunctional deterioration following treatment, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2090123224001255

Low-frequency magnetic field therapy for glioblastoma We found that magnetic fields can mimic the effects of chemotherapy drugs, with efficacy equivalent to the drugs themselves. Abstract. Background. Glioblastoma ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT05410301

Golden Halo, Static Magnetic and Electric Field Device, in ... Outcome Measure, Measure Description, Time Frame. Greater than or equal to 80% sBE compliance as determined by device pressor sensors, participant reporting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7819711/

Exposure to static magnetic and electric fields treats type 2 ... We report that static magnetic and electric fields (sBE) noninvasively modulate the systemic GSH-to-GSSG redox couple to promote a healthier systemic redox ...

7. nist.gov nist.gov/document/nist-s-7101-53magnetic-field-safety01052021pdf

Magnetic Field Safety (a) The primary safety concern with exposure to static and time-varying magnetic fields. 92 is the attraction of magnetic objects in or on ...

8. icnirp.org icnirp.org/cms/upload/publications/ICNIRPstatgdl.pdf

on limits of exposure to static magnetic fields Safety authorities need to ensure that there are restrictions to protect individuals who are wearing im- planted ferromagnetic or electronic medical devices sen ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6169123/

Does Exposure to Static Magnetic Fields Generated by ... These data suggest that in healthy individuals, reaction time and working memory can be influenced by the movements of the body around a MRI scanner.