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NCT Number: NCT07369960

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

This study explores a safe and effective new approach to improve language function in children with Global Developmental Delay (GDD). 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 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.

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Key information

Conditions

Developmental Delay Disorder Communication Disorders Developmental Disabilities Global Developmental Delay Language Disorders in Children Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Repetitive Transcranial Magnetic Stimulation (rTMS) Signs and Symptoms

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Jishou, Hunan, 416000, China

Location status: Recruiting

Location contact

Shentang Li, MD

CONTACT

[email protected]

+86 18874093634

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 2-5 years old, regardless of gender.
  • 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.
  • 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.
  • The child is able to cooperate with the completion of rTMS treatment and language assessment and has no serious behavioral problems.
  • Written informed consent obtained from the child's legal guardian. Exclusion Criteria
  • 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.
  • Other serious neurological conditions that may affect language function (e.g., cerebral palsy, progressive neurological disorders, etc.).
  • 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.

Treatment and study plan

Transcranial magnetic stimulation

Behavioral

The stimulation protocol consists of the following parameters: frequency of 10 Hz, intensity at 80% of the resting motor threshold (RMT), 30 pulses per train, 3-second train duration, and a 17-second inter-train interval. Each session comprises 1800 pulses in total, lasting 20 minutes. In addition to language training, participants will receive High-Frequency rTMS as a group-specific intervention. The rTMS will be administered 5 minutes prior to each language training session to leverage the post-stimulation "time window" and potentially enhance training efficacy. The entire study will last approximately 1 months, including 2 weeks of treatment and 2 weeks of follow-up.

individualized language training

Behavioral

individualized language training

Primary outcomes

  1. Change from Baseline in Language Developmental Quotient (DQ) via Gesell Developmental Schedules

    Time frame: Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).

    The language subscale of the Gesell Developmental Schedules is used to evaluate a child's language development. The result is expressed as a Developmental Quotient (DQ), a continuous score where 100 represents performance at the exact chronological age level. A higher DQ indicates better language abilities.

Secondary outcomes

  1. Change from Baseline in Language Developmental Stage via Sign-Significate Relations (S-S) Assessment

    Time frame: Baseline (Day 0), Week 2 (End of intervention), and Week 4 (Follow-up).

    The S-S method is a standardized tool for the detailed diagnosis and classification of language developmental delay in children. It assesses both language comprehension and expression abilities, assigning the child to a specific developmental stage.The core outcome is the assigned Stage (I to V, with subdivisions). Higher stages indicate more advanced language development. For analysis, stages are often converted to an ordinal numerical score (e.g., Stage I=1, Stage II=2, etc.). The minimum score is 1 (lowest stage), and the maximum is 5 (highest stage).

  2. Number of Participants with the Systematic Assessment for Treatment of Emergent Events (SAFTEE) [Safety and Tolerability]

    Time frame: From the start of intervention (Day 1) through the final follow-up (Week 4).

    Safety will be assessed by recording the incidence and severity of all adverse events (AEs) reported during the study. AEs include but are not limited to: headache, dizziness, scalp discomfort, tinnitus, irritability, and seizures. Severity will be graded as mild, moderate, or severe.

Study contacts

Contact information is provided by the study sponsor or research team.

Fangkun Liu, MD, MD

CONTACT

[email protected]

+86 15874290600

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Collaborators

  • Xiangxi Autonomous Prefecture People's Hospital

Registry information

Official study title

Randomized Controlled Study for Repetitive Transcranial Magnetic Stimulation Combined With Language Training in Children With Language Disorders in Children With Global Developmental Delay

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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