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Could a daily brain zapping helmet ease autism symptoms in kids?

NCT ID NCT07276555

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test whether a device called NeuroCytotron, which sends low-energy magnetic pulses to specific brain areas, can safely improve social communication and reduce repetitive behaviors in children with autism. 256 children aged 3 to 12 will be randomly assigned to receive either real or sham (placebo) treatments for 28 days. Neither the families nor the researchers will know who gets the real treatment, and the main goal is to see if the active group shows greater improvement on standard autism rating scales.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NeuroCytotron device (low-energy pulsed electromagnetic fields)
What this could lead to
If it works, this could offer a new, noninvasive treatment option to ease core autism symptoms like social communication difficulties and repetitive behaviors in children.
What could go wrong
This is an early-stage trial with no prior human data, so the treatment may not work better than placebo. Risks include discomfort from lying still, anxiety, and possible side effects from sedation needed for MRI scans.

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

About 256 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

3 to 12 years

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: * Male or female subjects with a confirmed diagnosis of ASD according to DSM-5 * criteria. * Subjects ≥ 3 and ≤ 12 years. * Subjects with ASD severity grade 1 to 2 according to DSM-5 criteria. * Participants must have functional use of language (i.e., at least some verbal * communication) to ensure that they engage with the assessments. * Stable on current medications for at least 4 weeks prior to the study. * To have the informed consent of the parents or legal representatives for the subject's * participation in the study. * Subjects must be physically able and willing to undergo the treatment sessions. * Subjects must be medically and psychologically stable to participate in the study. Exclusion Criteria: * Presence of medical conditions that could contraindicate the use of NeuroCytotron, * such as severe neurological disorders and difficult-to-control epilepsy. * uncontrolled epilepsy is defined as: more than 1 generalized seizure in any month within the 3 months prior to the day 1 visit, or * history of any of the following within 9 months prior to the day 1 visit: prolonged seizures or repetitive seizure activity requiring administration of a rescue benzodiazepine (oral, rectal, etc.) more than once a month, seizures lasting more than 10 minutes, status epilepticus or epilepsy with autonomic involvement. * Concurrent participation in other therapies or interventions for autism during the * study period and within the last 6 months. * Logistical or situational limitations that prevent regular attendance at treatment * sessions. * History of significant adverse reactions to similar treatments or involving the use of anesthesia. * Presence of serious behavioral problems or aggression that may affect the safety of the subject or staff during treatment sessions. * Current or recent (previous 14 days) history of clinically significant bacterial, fungal, viral or mycobacterial infection. * Presence of implanted medical devices or metallic foreign bodies that are not compatible with magnetic resonance imaging (MRI) or with the NeuroCytotron device, including but not limited to pacemakers, cochlear implants, deep brain stimulators, spinal cord stimulators, or any ferromagnetic implants. * Participants diagnosed with ASD will be excluded from the protocol if they present any of the following conditions identified through imaging studies: * Major Structural Lesions: * Primary or metastatic brain tumors that compromise general neurological function. * High-Risk Vascular Abnormalities: * Arteriovenous malformations or aneurysms with an immediate risk of rupture or bleeding. * Evidence of Acute Neurological Damage: * Recent cerebral infarction (\< 3 months). * Active intracranial hemorrhage. * Pathologies Interfering with Outcome Assessment: * Severe cerebral atrophy that significantly impacts the likelihood of response to treatment. * Severe congenital brain anomalies unrelated to the primary diagnosis of autism. * Active Pathologies Incompatible with the Protocol: * Intracranial infections, abscesses, or any evidence of active inflammation seen in imaging studies.

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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.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • NeuroCytonix Mexico

    San Pedro Garza García, Nuevo León, 66224, Mexico

  • NeuroCytonix, Inc.

    Rockville, Maryland, 20850, United States

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