Magnetic helmet trial aims to slow deadly brain tumors
NCT ID NCT06533163
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot trial tests a portable, wearable device that delivers low-intensity magnetic therapy to people with newly diagnosed glioblastoma, an aggressive brain cancer. The study will enroll 30 adults who have had surgery and are able to receive standard radiotherapy. The main goal is to check the device's safety, but researchers will also monitor tumor response on MRI scans and progression-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Oncomagnetic device (wearable magnetic therapy device)
- What this could lead to
- If it works, this could point toward a noninvasive way to slow glioblastoma growth alongside standard care.
- What could go wrong
- This is a very early pilot trial with only 30 people, focused on safety. It may not show any benefit, and the device is not a proven treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The subject is at least 18 years of age. 2. The subject previously had maximal safe resection (MSR) for glioblastoma (GBM) per the discretion of the investigator and is able to receive standard radiotherapy (unless contraindicated or refused by the subject) 3. The subject has a newly confirmed diagnosis of GBM per WHO classification criteria. 4. The subject has pre-op, post-surgical MRI and RX planning MRI scans available for Investigator review. 5. The subject has a confirmed unmethylated MGMT promoter status. 6. The subject has a KPS ≥ 70. 7. The subject's life expectancy is \>12 weeks. 8. The subject is no longer taking corticosteroids. 9. The subject has signed and dated the consent form. 10. The subject has stated understanding and willingness to comply with all clinical investigation procedures and availability for the duration of the clinical investigation. 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 \< 1500 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinical Center Lünen
RECRUITINGLünen, North Rhine-Westphalia, 44534, Germany
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Clinical Center Stuttgart
RECRUITINGStuttgart, Baden-Wurttemberg, 70174, Germany
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Medical Center Mannheim
RECRUITINGMannheim, 68167, Germany
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Technical University of Munich
RECRUITINGMünchen, Bavaria, 81675, Germany
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University Hospital Bonn
RECRUITINGBonn, North Rhine-Westphalia, 53127, Germany
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University Hospital Leipzig
RECRUITINGLeipzig, Saxony, 04103, Germany
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