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Could a magnetic helmet help kids with delayed speech?

NCT ID NCT07369960

Symptom relief Sponsor: Xiangya Hospital of Central South University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether combining a gentle, non-invasive brain stimulation technique called rTMS with personalized language training can improve language skills in children aged 2 to 5 with global developmental delay. About 50 children will be split into two groups: one gets both rTMS and language training, the other gets language training alone. The goal is to see if the brain stimulation boosts the effects of therapy over a one-month period.

What this could mean

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

Active substance
repetitive transcranial magnetic stimulation (rTMS)
What this could lead to
If it works, this could offer a safe, non-drug way to boost language abilities in young children with developmental delays.
What could go wrong
This is a small, early-stage study with only 50 children, so results may not apply to everyone. The treatment is short-term, and long-term benefits are unknown.

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 50 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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

2 to 5 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 1. Children aged 2-5 years old, regardless of gender. 2. Meet the diagnostic definition of GDD in China's Diagnostic Guidelines for Global Developmental Delay (2024), confirmed by Gesell Developmental Schedules (GDS). Language domain Developmental Quotient (DQ) ≤ 75. A DQ ≤ 75 is found in at least one of the four developmental domains: gross motor, fine motor, adaptive behavior, and personal-social conduct. Mild-moderate GDD is selected for the study. 3. The presence of significant language developmental delay, the language ability is significantly lower than children of the same age and the same intellectual level, confirmed by the standardized scale of Sign-Significate Relations (S-S) assessment. 4. The child is able to cooperate with the completion of rTMS treatment and language assessment and has no serious behavioral problems. 5. Written informed consent obtained from the child's legal guardian. Exclusion Criteria 1\. History of epilepsy or convulsive seizures. 2. Having metal implants in the skull (e.g. aneurysm clips, metal stents, etc.) and electronic devices such as pacemakers and cochlear implants in the body. 3\. Other serious neurological conditions that may affect language function (e.g., cerebral palsy, progressive neurological disorders, etc.). 4\. Have a diagnosis of ASD. 5. Have a severe hearing or visual impairment. 6. Participation in other clinical trials that may affect speech function. 7. Skin lesions or infection at the scalp treatment site. 8. The fontanelle has not yet closed. 9. Previous rTMS treatment in the last 3 months. 10. Developmental quotient \< 40 in any developmental domains; other circumstances that prevented cooperation with the study.

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Conditions

The condition(s) this trial relates to.

developmental disability global developmental delay with or without impaired intellectual development language disorder learning disability

As listed by the trial registrant

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

Developmental delay (disorder) Global developmental delay Language disorders in children Repetitive transcranial magnetic stimulation (RTMS) Transcranial magnetic stimulation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • Xiangxi Autonomous Prefecture People's Hospital, The intersection of Century Avenue and Jianxin Road in Qianzhou Sub-district, Jishou (416000), Hunan, China.

    RECRUITING

    Jishou, Hunan, 416000, China

More trials for these conditions

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