Electric field helmet tested for tough brain tumor – but only one patient tried it

NCT ID NCT03450850

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

1 person

The number who actually took part.

Started

May 2020

Finished

Aug 2025

Lead sponsor

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

22 years and older

Sex

Anyone

Healthy volunteers

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

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

  • University of California, Irvine

    Orange, California, 92868, United States

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