pBFS Guided aiTBS Over Language Network for ASD Child

NCT06950437 | Recruiting

• 1 other identifier: NGASD002DMC_150
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to evaluate the efficacy and safety of precision neuromodulation in improving language ability in children with autism spectrum disorder (ASD) who also have language development delay. The neuromodulation will be delivered using the accelerated intermittent theta burst stimulation (aiTBS) protocol, targeting the language network in the left superior frontal gyrus (SFG), guided by personalized Brain Functional Sector (pBFS) technology.

Conditions

Autism Spectrum Disorder; Language Delay

Keywords

ASD; language delay; aiTBS; precision neuromodulation

Outcome Measures

Primary Outcomes (1)

• CLAS-TP score change after treatment

  The score changes of combined CLAS-TP (Child Language Assessment Scale - Test for Preschoolers) score at 12-week from baseline. Higher scores mean a better outcome.

  Pre-treatment (baseline), post-treatment (12-week)

Secondary Outcomes (4)

• CLAS-TP total score change from baseline to follow-up

  Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

• CLAS-TP subscale score change from baseline to follow-up

  Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

• WPPSI language score change from baseline to follow-up

  Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

• ADOS-2 SA score change from baseline to follow-up

  Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

Other Outcomes (4)

• SCQ score change from baseline to follow-up

  Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

• ATEC score change from baseline to follow-up

  Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

• CBCL score change from baseline to follow-up

  Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

Study Arms (2)

active iTBS group

EXPERIMENTAL

active iTBS over SFG

Device: active iTBS; Behavioral: speech therapy

Sham group

SHAM COMPARATOR

sham iTBS over SFG

Device: Sham iTBS; Behavioral: speech therapy

Interventions

active iTBS DEVICE

Participants will undergo three iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Individualized targets will be generated using the pBFS technique.

active iTBS group

Sham iTBS DEVICE

Participants will undergo three sham iTBS sessions per day, with 1800 pulses per session, over a 12-week period. Sham stimulation will be delivered through a sham coil with the identical appearance as real coil. Individualized targets will be generated using the pBFS technique.

Sham group

speech therapy BEHAVIORAL

Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.

Sham group; active iTBS group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Professionally diagnosed with ASD per DSM - 5 criteria.
• Aged 3 - 6.5 years, either gender.
• ADOS-2 results meet ASD standard cut - off.
• SCQ score: ≥15 (age ≥ 4 years) or ≥11 (age \< 4 years).
• Co-existing language disorder not explaining ASD symptoms. No organic speech organ lesions. CNBS-R2016 and CLAS-TP language-related equivalent age \> 18 months; any CLAS-TP dimension score \< 6.
• Mandarin is the daily communication language.
• May have intellectual/global developmental delay not explaining ASD symptoms.
• Guardians volunteer, can cooperate in treatment and sign informed consent.

You may not qualify if:

• Identified genetic pathogenic factors; current/past comorbid severe disorders (ADHD, Tourette's, etc.).
• Serious self-harm in the past year.
• Severe sensory/motor disorders precluding cooperation.
• History of epileptic seizures.
• Serious organic diseases, especially brain related.
• Contraindications for MRI/TMS (metal/implants).
• Respiratory/circulatory diseases with sedation risk.
• Illiterate guardians unable to handle informed consent/questionnaires.
• Received neuromodulation in the past 3 months.
• Currently in other clinical trials.
• Deemed unfit by the researcher.

Sponsors & Collaborators

• Beijing Changping Tianhe Research Institute of Brain Science: lead
• Peking University Sixth Hospital: collaborator
• Shanghai Yangzhi Rehabilitation Hospital: collaborator

Study Sites (1)

Peking University Sixth Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Language Development Disorders

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Xinyu Duan

CONTACT

13691009590; xinyu.duan@neuralgalaxy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 30, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-02

Locations

CN (1)