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

NCT07369960 | Recruiting

• 1 other identifier: EC-LCKY2025078
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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 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.

Conditions

Repetitive Transcranial Magnetic Stimulation (rTMS); Developmental Delay Disorder; Global Developmental Delay; Language Disorders in Children

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (2)

Transcranial magnetic stimulation

EXPERIMENTAL

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. It will be administered 5 minutes prior to individualized language training to take advantage of the post-stimulation "time window" and potentially enhance training efficacy.

Behavioral: Transcranial magnetic stimulation

Control group

SHAM COMPARATOR

Children in the control group will receive sham stimulation using a sham stimulation coil with identical parameters, positioning, and procedures. The sham stimulation will also be administered 5 minutes prior to individualized language training.

Behavioral: Transcranial magnetic stimulation

Interventions

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. Children in the experimental group will receive active rTMS, while those in the control group will receive sham stimulation. The entire study will last approximately 1 months, including 2 weeks of treatment and 2 weeks of follow-up.

Control group; Transcranial magnetic stimulation

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Xiangxi Autonomous Prefecture People's Hospital: collaborator

Study Sites (1)

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

RECRUITING

MeSH Terms

Conditions

Developmental Disabilities; Learning Disabilities

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Fangkun Liu, MD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangkun Liu, MD, MD

CONTACT

+86 15874290600; liufangkun@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, their guardians, the language therapists providing individualized training, and the outcome assessors conducting language evaluations will all be blinded to group allocation. Outcome assessors will have no involvement in the randomization or intervention processes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-01

Locations

CN (1)