pBFS Guided aiTBS Over Language Network for ASD Child
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorBeijing Changping Tianhe Research Institute of Brain Science
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
active iTBS
DeviceParticipants 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
DeviceParticipants 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
BehavioralSpeech therapy will be delivered between iTBS/sham sessions. Two 30-minutes trainings every day.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: active iTBS groupExperimental treatment 2 interventions
Group B: Sham groupSham comparator 2 interventions
Trial outcomes
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.
Time frame
Pre-treatment (baseline), post-treatment (12-week)Secondary outcomes
1
CLAS-TP total score change from baseline to follow-up
Higher scores mean a better outcome.
Time frame
Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)2
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.
Time frame
Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)3
WPPSI language score change from baseline to follow-up
Higher scores mean a better outcome.
Time frame
Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)4
ADOS-2 SA score change from baseline to follow-up
Higher scores mean a worse outcome.
Time frame
Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)Other outcomes
1
SCQ score change from baseline to follow-up
Higher scores mean a worse outcome.
Time frame
Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)2
ATEC score change from baseline to follow-up
Higher scores mean a worse outcome.
Time frame
Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)3
CBCL score change from baseline to follow-up
Higher scores mean a worse outcome.
Time frame
Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)4
QoL score change from baseline to follow-up
Higher scores mean a better outcome.
Time frame
Pre-treatment (baseline), post-treatment (12-week), follow-up (24-week)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Changping Tianhe Research Institute of Brain Science
Lead sponsor
Peking University Sixth Hospital
Collaborator
Shanghai Sunshine Rehabilitation Center
Collaborator
Source ClinicalTrials.gov