Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-04-25
2027-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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active iTBS group
active iTBS over SFG
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.
speech therapy
Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.
Sham group
sham iTBS over SFG
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.
speech therapy
Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.
Interventions
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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.
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.
speech therapy
Speech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.
Eligibility Criteria
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Inclusion 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
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.
3 Years
6 Years
ALL
No
Sponsors
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Peking University Sixth Hospital
OTHER
Shanghai Yangzhi Rehabilitation Hospital
UNKNOWN
Beijing Changping Tianhe Research Institute of Brain Science
OTHER
Responsible Party
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Locations
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Peking University Sixth Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Li Yang
Role: primary
Other Identifiers
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NGASD002DMC_150
Identifier Type: -
Identifier Source: org_study_id
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