Electric field helmet tested for tough brain tumor – but only one patient tried it
NCT ID NCT03450850
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a wearable device called NOVOTTF-200A in people with recurrent Grade III astrocytoma, a type of brain cancer. The device delivers low-intensity electric fields to the brain to slow tumor growth. Only 1 participant was enrolled, and the main goal was to see if the tumor stopped growing for six months. Because of the tiny sample size, the results are very limited and cannot tell us if the device truly works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NOVOTTF-200A (a wearable device that delivers electric fields to the brain to slow tumor growth)
- What this could lead to
- If it works, this device could offer a new way to control tumor growth in patients with recurrent Grade III astrocytoma without using chemotherapy or other drugs.
- What could go wrong
- This trial enrolled only 1 person, so results cannot be generalized. The device must be worn at least 18 hours a day, which may be burdensome, and side effects or lack of benefit are possible.
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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1 person
The number who actually took part.
- Started
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May 2020
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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22 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. Understand and voluntarily sign and date an informed consent document before any study related assessments/procedures are conducted. 2. Males and females of age ≥18 years at the time of the signing of the informed consent document. 3. All subjects must have histologic evidence of G3 MG and radiographic evidence of recurrence or disease progression (defined as either a greater than 25% increase in the largest bi-dimensional product of enhancement, a new enhancing lesion or a significant increase in T2 FLAIR). 4. Subjects with archival tumor tissue suitable for genetic testing must give permission to access and test the tissue; subjects without archival tumor tissue are eligible. 5. No prior treatment with BEV or any anti-angiogenesis agents. 6. At least 4 weeks from surgical resection and 12 weeks from end of radiotherapy prior to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are 8 weeks apart. 7. All AEs resulting from prior chemotherapy, surgery or radiotherapy must have resolved to NCI-CTCAE (v. 4.03) Grade ≤1 (except for laboratory parameters outlined below). 8. Laboratory results within 7 days prior to NOVOTTF-200A administration (transfusions and/or growth factor support may be used at the discretion of the Investigator during Screening): * Hemoglobin ≥9 g/dL. * Absolute neutrophil count (ANC) ≥1.5 × 109/L. * Platelet count ≥100 × 109/L. * Serum bilirubin ≤1.5 × upper limit of normal (ULN) or ≤3 × ULN if Gilbert's disease is documented. * Aspartate transaminase (AST) ≤ 2.5 ULN. * Serum creatinine ≤1.5 × ULN. 9. Karnofsky Performance Status (KPS) score ≥70%. 10. Willing and able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: 1. The presence of 1p19q LOH which is diagnostic for anaplastic oligodendroglioma (AO). 2. Co-medication that may interfere with study results, e.g., immunosuppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the investigator. Subjects should be on a stable dose of steroids for at least 1 week prior to study beginning.) 3. Chemotherapy administered within 4 weeks (6 weeks for an IV nitrosoureas and 12 weeks for an implanted nitrosoureas wafer) prior to Day 1 of study treatment. 4. Pregnancy or breastfeeding. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics \& psychiatric illness/social situations that would limit adherence with study requirements, or disorders associated with significant immunocompromised state. 6. Known previous/current malignancy requiring treatment within ≤ 3 years except for cervical carcinoma in situ, squamous or basal cell skin carcinoma and superficial bladder carcinoma. 7. Any comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator.
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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.
Contacts and locations
Locations
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University of California, Irvine
Orange, California, 92868, United States
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Other studies related to the condition(s) this trial covers.
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