Transcranial Magnetic Stimulation Combined With Language Training for Language Disorders in Global Developmental Delay

Central South University

Status: Not yet enrolling

Conditions: Language Disorders in Children; Transcranial Magnetic Stimulation; Developmental Delay Disorder

Treatments: Behavioral: Transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07369960

EC-LCKY2025078

Details and patient eligibility

About

This study explores a safe and effective new approach to assisting children with Global Developmental Delay (GDD) and comorbid language disorders. Conducted at Xiangxi Autonomous Prefecture People's Hospital, the study will recruit approximately 50 children aged 2 to 5 years. Participants will be randomly assigned to one of two groups: one receiving personalized language training combined with non-invasive, painless repetitive Transcranial Magnetic Stimulation (rTMS) to activate language regions of the brain, and a control group receiving personalized training alongside sham stimulation for comparative analysis. The study spans one month, including a two-week intervention period followed by a two-week follow-up to evaluate the efficacy and sustainability of the combined therapy. This study has been rigorously reviewed and approved by the hospital's Ethics Committee.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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), and the Developmental Quotient (DQ) of the language domain is ≤75. At least one other of the four developmental domains, adaptive behavior, personal-social behavior, gross motor, and fine motor, had a DQ ≤ 75. Mild-moderate GDD was 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 TMS treatment and language assessment and has no serious behavioral problems.
5. The guardian of the child understands the content of this study and voluntarily signs the written informed consent.

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 Autism Spectrum Disorder (ASD). 5. have a severe hearing or visual impairment. 6. participation in other clinical trials that may affect speech function. 7. breakage 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Transcranial magnetic stimulation

Experimental group

Description:

Receiving "true" high-frequency repetitive transcranial magnetic stimulation and personalized language training

Treatment:

Behavioral: Transcranial magnetic stimulation

Control group

Sham Comparator group

Description:

Receiving simulated pseudo-stimulation and personalized language training

Treatment:

Behavioral: Transcranial magnetic stimulation