Golden Halo, Static Magnetic and Electric Field Device, in Recurrent 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 that creates magnetic and electric fields, used while patients sleep. It targets adults whose brain cancer has returned after initial treatment. The device is combined with standard chemotherapy to see if it helps fight the cancer more effectively. The approach aims to suppress the growth of cancer cells.

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.

Is the Static Magnetic and Electric (sBE) device generally safe for humans?

Research on static magnetic fields shows no long-term harmful effects, but some people might feel temporary dizziness or nausea. There is limited data on long-term safety, so it's important to follow safety guidelines. ^{1 2 3 4 5}

How does the Static Magnetic and Electric (sBE) device treatment differ from other treatments?

The Static Magnetic and Electric (sBE) device treatment is unique because it uses a combination of magnetic and electric fields to potentially influence the body's natural processes, unlike traditional treatments that may rely on medication or surgery. This approach is novel as it aims to harness physical forces rather than chemical interactions to achieve therapeutic effects. ^{6 7 8 9 10}

What data supports the effectiveness of the Static Magnetic and Electric (sBE) device treatment?

Research suggests that static magnetic fields may help reduce pain in conditions like chronic lumbar radicular pain and fibromyalgia, with some studies showing a trend towards pain relief with stronger magnets. However, more extensive studies are needed to confirm these effects. ^{11 12 13 14 15}

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

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Static magnetic field therapy for carpal tunnel syndrome: a feasibility study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Low intensity permanent magnets in the treatment of chronic lumbar radicular pain. [2007]

3. China pubmed.ncbi.nlm.nih.gov

[Effects of static magnetic field at different times on the proliferation and differentiation of osteoblasts in vitro]. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Histological analysis of the effects of a static magnetic field on bone healing process in rat femurs. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Static magnetic fields for treatment of fibromyalgia: a randomized controlled trial. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

MR procedures: biologic effects, safety, and patient care. [2008]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Magnetic field interactions between current consumer electronics and cardiac implantable electronic devices. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Electromagnetic interference effect of dental equipment on cardiac implantable electrical devices: A systematic review. [2021]

9. Italy pubmed.ncbi.nlm.nih.gov

Patient safety issues in magnetic resonance imaging: state of the art. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Static fields: biological effects and mechanisms relevant to exposure limits. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

The physical meaning of the magnetic scalar potential and its use in the design of hermetic electromagnetic coils. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Convex optimisation of gradient and shim coil winding patterns. [2014]

13. England pubmed.ncbi.nlm.nih.gov

Two simple modifications to improve the magnetic field profile in radial magnetic systems. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

A Bitter-type electromagnet for complex atomic trapping and manipulation. [2023]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Solenoid Configurations and Gravitational Free Energy of the AdS-Melvin Spacetime. [2021]