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Can a magnetic helmet slow ALS? trial tests brain stimulation at home

NCT ID NCT06834269

Disease control Sponsor: Campus Bio-Medico University Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether transcranial static magnetic field stimulation (tSMS), delivered via a helmet worn at home, can slow the progression of amyotrophic lateral sclerosis (ALS). About 60 adults with recent-onset ALS will use the device for two daily sessions of 120 minutes over 12 months. The study tracks changes in a blood biomarker called neurofilament light (NfL) and clinical progression using the ALSFRS-R scale, and it explores whether these markers can predict response to treatment.

What this could mean

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

Active substance
transcranial static magnetic field stimulation (tSMS), a helmet delivering magnets to the motor cortex
What this could lead to
If it works, this could offer a non-invasive, home-based way to slow ALS progression and give doctors a blood test to track the disease.
What could go wrong
The trial is small and early, so any benefit may be modest or not hold up in larger studies. Wearing a magnetic helmet for hours daily may be impractical, and the treatment could fail to change the disease course.

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 60 people

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

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

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

18 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: * age ≥ 18 * diagnosis of possible, probable or definite ALS according to revised El Escorial criteria and Awaji-Shima criteria * disease duration \< 24 months * ALSFRS-R \> 30 at the recruitment * ALSFRS-R decline \> 1 in the at least 3-months period before the intervention * normal respiratory functionality at the preliminary evaluation (M-3), assessed in the previous month (FVC ≥ 75% and ALSFRS-R items 10,11,12 \> 4) * treatment with riluzole 50 mg x 2/die Exclusion Criteria: * inclusion in other clinical trials * presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy) * unable to perform spirometry due to severe bulbar involvement * contraindications to magnetic fields exposure * pregnancy or breastfeeding * history of epilepsy or seizures * use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines. * cognitive impairment * lack of informed consent

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis (ALS)

Contacts and locations

Locations

  • Fondazione Policlinico Campus Bio-Medico

    Roma, RM, 00128, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.