pBFS Guided aiTBS Over Language Network for ASD Child

Transcranial Magnetic Stimulation Guided by Personalized Brain Functional Sectors (pBFS) for Language Deficit Comorbid in Autism Spectrum Disorder Child: a Multi-center, Randomized, Sham-controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Language Delay
• Intervention / Treatment: Device: active iTBS; Behavioral: speech therapy; Device: Sham iTBS

Detailed Description

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder often accompanied by language delay. Emerging evidence indicates that Transcranial Magnetic Stimulation (TMS) has been effective in restoring language ability in post-stroke aphasia, but its efficacy in developmental language disorders remains unknown.

By leveraging the personalized Brain Functional Sector (pBFS) technique and task-free functional MRI scans, we can accurately locate the individual language function brain network. Considering the accessibility and comfort of neuromodulation, we will stimulate the language network node in the superior frontal gyrus (SFG) for 12 weeks.

In this study, participants meeting the inclusion and exclusion criteria will be randomly assigned to either the active or sham iTBS (intermittent theta burst stimulation) groups at a ratio of 2:1. The treatment protocol lasts for 12 weeks, with sessions held 5 days a week and 3 iTBS sessions over the SFG per day. The inter-session interval is set at 50 minutes, along with speech therapy. Clinical evaluations focusing on language and ASD symptoms will be conducted at baseline, after the 12-week treatment period, and at 24-week follow-up after the start of treatment.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinyu Duan; Phone Number: 13691009590; Email: xinyu.duan@neuralgalaxy.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Sixth Hospital
    • Contact: Li Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Professionally diagnosed with ASD per DSM - 5 criteria.
2. Aged 3 - 6.5 years, either gender.
3. ADOS-2 results meet ASD standard cut - off.
4. SCQ score: ≥15 (age ≥ 4 years) or ≥11 (age < 4 years).
5. 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.
6. Mandarin is the daily communication language.
7. May have intellectual/global developmental delay not explaining ASD symptoms.
8. Guardians volunteer, can cooperate in treatment and sign informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active iTBS group; active iTBS over SFG	Device: active iTBS; 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.; Behavioral: speech therapy; Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.
Sham Comparator: Sham group; sham iTBS over SFG	Behavioral: speech therapy; Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.; Device: Sham iTBS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CLAS-TP total score change from baseline to follow-up	Higher scores mean a better outcome.	Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
CLAS-TP subscale score change from baseline to follow-up	For the story comprehension subscale, only participants who had non-zero point were included. Higher scores mean a better outcome.	Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
WPPSI language score change from baseline to follow-up	Higher scores mean a better outcome.	Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
ADOS-2 SA score change from baseline to follow-up	Higher scores mean a worse outcome.	Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCQ score change from baseline to follow-up	Higher scores mean a worse outcome.	Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
ATEC score change from baseline to follow-up	Higher scores mean a worse outcome.	Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
CBCL score change from baseline to follow-up	Higher scores mean a worse outcome.	Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)
QoL score change from baseline to follow-up	Higher scores mean a better outcome.	Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)

Collaborators and Investigators

• Sponsor: Beijing Changping Tianhe Research Institute of Brain Science
• Collaborators: Peking University Sixth Hospital; Shanghai Yangzhi Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: ASD; language delay; aiTBS; precision neuromodulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Communication Disorders; Language Disorders; Autism Spectrum Disorder; Language Development Disorders
• Other Study ID Numbers: NGASD002DMC_150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No