Trial Outcomes & Findings for Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial(Ⅱ) (NCT NCT05472870)
NCT ID: NCT05472870
Last Updated: 2024-08-21
Results Overview
Social Response Scale (SRS) is a parent questionnaire used to assess the presence and severity of social impairment. The SRS generates a total score and five subscale scores (social awareness, social cognition, social communication, social motivation, and autistic mannerisms), and 5 subscales scores are summed to compute the total score; higher scores indicate greater social impairment. The SRS total score range is "0-195", the social awareness subscale score range is "0-24", the social cognition subscale score range is "0-36", the social communication subscale score range is "0-66", the social motivation subscale score range is "0-33", and the autistic mannerisms subscale score range is "0-36". We collected the SRS from baseline to 1 month follow-up to evaluate the effect of rTMS treatment on ASD syptoms among these children.
COMPLETED
NA
30 participants
Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.
2024-08-21
Participant Flow
Participant milestones
| Measure |
rTMS Group
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial(Ⅱ)
Baseline characteristics by cohort
| Measure |
rTMS Group
n=30 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
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Age, Continuous
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7.06 years
STANDARD_DEVIATION 1.55 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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24 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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30 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
China
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30 participants
n=5 Participants
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Full Scale intelligence quotient (FSIQ)
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74.97 units on a scale
STANDARD_DEVIATION 24.70 • n=5 Participants
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Childhood Autism Rating Scale (CARS)
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33.48 units on a scale
STANDARD_DEVIATION 2.59 • n=5 Participants
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Autism Diagnostic Observation Schedule (ADOS)
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13.73 units on a scale
STANDARD_DEVIATION 2.74 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.Social Response Scale (SRS) is a parent questionnaire used to assess the presence and severity of social impairment. The SRS generates a total score and five subscale scores (social awareness, social cognition, social communication, social motivation, and autistic mannerisms), and 5 subscales scores are summed to compute the total score; higher scores indicate greater social impairment. The SRS total score range is "0-195", the social awareness subscale score range is "0-24", the social cognition subscale score range is "0-36", the social communication subscale score range is "0-66", the social motivation subscale score range is "0-33", and the autistic mannerisms subscale score range is "0-36". We collected the SRS from baseline to 1 month follow-up to evaluate the effect of rTMS treatment on ASD syptoms among these children.
Outcome measures
| Measure |
rTMS Group
n=30 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
rTMS Group (Preschool Age)
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
Children who are not yet in school need to complete the preschool-age version
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Social Response Scale (SRS) Scores
Pre-intervention
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94.27 score on a scale
Standard Deviation 20.26
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—
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Social Response Scale (SRS) Scores
Post-intervention
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81.50 score on a scale
Standard Deviation 21.27
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—
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Social Response Scale (SRS) Scores
1month follow-up
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77.67 score on a scale
Standard Deviation 20.13
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—
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SECONDARY outcome
Timeframe: Baseline, and 4 weeks after the completion of intervention.CARS is a behaviour-rating scale used to assess the presence and severity of the symptoms of autism spectrum disorder(ASD), with scores ranging from 15 to 60 and high scores indicating severe symptoms. Change of the CARS from baseline to 1 months after treatment to evaluate the effect of rTMS treatment on ASD. children.
Outcome measures
| Measure |
rTMS Group
n=30 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
rTMS Group (Preschool Age)
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
Children who are not yet in school need to complete the preschool-age version
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|---|---|---|
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Childhood Autism Rating Scale (CARS)
pre-intervention
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33.48 score on a scale
Standard Deviation 2.59
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—
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Childhood Autism Rating Scale (CARS)
1month follow-up
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32.83 score on a scale
Standard Deviation 2.66
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—
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SECONDARY outcome
Timeframe: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.Population: Three parents of participants did not complete the questionnaire
BRIEF is a quick and efficient measure of executive function(have school-age version (BRIEF-S) and preschool version (BRIEF-P)), we asked parents to complete the 86-item (BRIEF-S) or 63-item (BRIEF-P) form to rate a child's executive functions (1-3 score) within the context of his everyday environments (home or school). Here we report the BRIEF composite score, BRIEF-S score range is 86 -258 and BRIEF-P score range is 63-189. The higer scores indicate more impairment in executive function. We evaluate the changes in executive function (EF) scores before and after cTBS treatment.
Outcome measures
| Measure |
rTMS Group
n=17 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
rTMS Group (Preschool Age)
n=10 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
Children who are not yet in school need to complete the preschool-age version
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Behavior Rating Inventory of Executive Function (BRIEF)
Pre-intervention
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153.76 score on a scale
Standard Deviation 20.55
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115.30 score on a scale
Standard Deviation 10.09
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Behavior Rating Inventory of Executive Function (BRIEF)
Post-intervention
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152.76 score on a scale
Standard Deviation 20.28
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117.60 score on a scale
Standard Deviation 14.24
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Behavior Rating Inventory of Executive Function (BRIEF)
1month follow-up
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149.12 score on a scale
Standard Deviation 18.35
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112.00 score on a scale
Standard Deviation 10.59
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SECONDARY outcome
Timeframe: Baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.Conners Parent Symptom Questionnaire (PSQ) is a questionnaire screening for children's behavioral problems (especially with ADHD), it has 48 items（4-stage: 0-3) that can be divided into 6 factors (conduct problems, learning problems, psychosomatic problems, impulsive-hyperactivity, anxiety, and hyperactivity index). Add the scores and divide by the item numbers of each factor to get Z score. Here we mainly observe the changes in Hyperactivity Index (HI) Z scores, it ranges from 0-3, a higher score mean a worse outcome.
Outcome measures
| Measure |
rTMS Group
n=30 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
rTMS Group (Preschool Age)
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
Children who are not yet in school need to complete the preschool-age version
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Conners Parent Symptom Questionnaire (PSQ)
1month follow-up
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1.10 score on a scale
Standard Deviation 0.34
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—
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Conners Parent Symptom Questionnaire (PSQ)
Pre-intervention
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1.20 score on a scale
Standard Deviation 0.49
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—
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Conners Parent Symptom Questionnaire (PSQ)
Post-intervention
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1.18 score on a scale
Standard Deviation 0.48
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—
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SECONDARY outcome
Timeframe: Baseline, and 4 weeks after the completion of intervention.Population: Three subjects did not cooperate with the test, so their data were excluded from the analysis
The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests for measuring single-word comprehension. The raw score ranges from 0-110, the higher scores mean a better outcome. we collected the PPVT raw score from baseline to 1 months after treatment to evaluate the effect of rTMS treatment on ASD children's words comprehension.
Outcome measures
| Measure |
rTMS Group
n=27 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
rTMS Group (Preschool Age)
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
Children who are not yet in school need to complete the preschool-age version
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|---|---|---|
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Peabody Picture Vocabulary Test（PPVT）
Pre-intervention
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67.78 score on a scale
Standard Deviation 27.23
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—
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Peabody Picture Vocabulary Test（PPVT）
1month follow-up
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76.11 score on a scale
Standard Deviation 26.89
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—
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SECONDARY outcome
Timeframe: Baseline and 4 weeks after the completion of intervention.Population: 8 subjects whose parents did not complete the follow-up scale or who had reached the highest measurable score on the scale in terms of ability (ceiling effect) were not included in the analysis
CCDI provides a powerful tool to assess early vocabulary development and the language skills of older children with developmental disorders and the effectiveness of their intervention. Here we collected the CCDI words produced score, it ranges from 0-798. The higher scores mean a better outcome.
Outcome measures
| Measure |
rTMS Group
n=22 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
rTMS Group (Preschool Age)
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
Children who are not yet in school need to complete the preschool-age version
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|---|---|---|
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Chinese Communicative Development Inventory (CCDI)
Pre-intervention
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733.00 score on a scale
Interval 615.25 to 789.5
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—
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Chinese Communicative Development Inventory (CCDI)
1month follow-up
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771.50 score on a scale
Interval 657.0 to 793.25
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—
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SECONDARY outcome
Timeframe: After the completion of 5-days intervention and 4 weeks after the completion of intervention.CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention. Here we used Clinical Global Impression of Improvement (CGI-I) to rate how much the patient's illness has improved or worsened relative to baseline (a seven-point scale: 1 = "very much improved" to 7 = "very much worse"). The CGI was carried out by trained clinical assessors according to children's CARS、ADOS assessment results and parent interviews before and after intervention. We calculated the number of subjects with improvement (CGI-I≤3).
Outcome measures
| Measure |
rTMS Group
n=30 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
rTMS Group (Preschool Age)
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
Children who are not yet in school need to complete the preschool-age version
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|---|---|---|
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Clinical Global Impression of Improvement (CGI-I)
Post-intervention
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20 Participants
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—
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Clinical Global Impression of Improvement (CGI-I)
1month follow-up
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27 Participants
|
—
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SECONDARY outcome
Timeframe: baseline, immediately after the completion of 5-days intervention, and 4 weeks after the completion of intervention.The Repetitive Behaviors Scale - Revised (RBS-R) is a 44-item (rated 0-3) questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders. The RBS-R provides a quantitative, continuous measure of the full spectrum of repetitive behaviors. The RBS-R consists of six subscales including: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior, that have no overlap of item content. Here we use the RBS-R total score, it ranges from 0-132, the higher score means worse repetitive behavior.
Outcome measures
| Measure |
rTMS Group
n=30 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
rTMS Group (Preschool Age)
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
Children who are not yet in school need to complete the preschool-age version
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|---|---|---|
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Repetitive Behaviors Scale - Revised (RBS-R)
Pre-intervention
|
7.00 score on a scale
Interval 4.75 to 9.0
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—
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Repetitive Behaviors Scale - Revised (RBS-R)
immediately after the completion of Post-intervention
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7.00 score on a scale
Interval 4.75 to 9.0
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—
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Repetitive Behaviors Scale - Revised (RBS-R)
4 weeks after the completion of 1month follow-up
|
5.5 score on a scale
Interval 3.75 to 8.0
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, immediately after the completion of 5-days intervention.Population: We successfully collected EEG data from 26 children before and after the intervention, and one patient was excluded after a quality control procedure. Due to limited implementation conditions (e.g., epidemics, installations) , we did not collect EEG data at 1-month follow-up. The phase locking value(PLV) and coherence (Coh) were not analyzed due to data and analyst issues.
For EEG data, we caculated the power spectral density (PSD) within the alpha frequency band (8-13 Hz) for all channels.
Outcome measures
| Measure |
rTMS Group
n=25 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
rTMS Group (Preschool Age)
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
Children who are not yet in school need to complete the preschool-age version
|
|---|---|---|
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Power Spectral Density (PSD) Within the Alpha Frequency Band
Pre-intervention
|
2.05 W/Hz
Standard Deviation 0.96
|
—
|
|
Power Spectral Density (PSD) Within the Alpha Frequency Band
Post-intervention
|
1.66 W/Hz
Standard Deviation 0.67
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, and 4 weeks after the completion of intervention.Population: 14 children having certain expression ability to complete MAIN test.
For a subset of ASD children with adequate expressive ability (those able to at least use phrases), we use Multilingual Assessment Instrument for Narratives (MAIN) tool to assess their narrative comprehension and production skills. In this test, children were asked to tell and retell the story and answer comprehension questions, and then assessors scored children's performance from four dimensions (i.e., story structure, structural complexity, and internal state terms and comprehension questions). The story structure score range is 0-18, structural complexity score range is 0-4, internal state terms score range is 0-no limit, and comprehension questions score range is 0-10. The higher score means better performance.
Outcome measures
| Measure |
rTMS Group
n=14 Participants
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
rTMS Group (Preschool Age)
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
Children who are not yet in school need to complete the preschool-age version
|
|---|---|---|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Telling_Story Structure_Pre-intervention
|
7.57 score on a scale
Standard Deviation 2.34
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Telling_Story Structure_1month follow-up
|
8.96 score on a scale
Standard Deviation 2.43
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Telling_Structural Complexity_Pre-intervention
|
2.11 score on a scale
Standard Deviation 0.59
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Telling_Structural Complexity_1month follow-up
|
2.50 score on a scale
Standard Deviation 0.55
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Telling_Internal States Terms_Pre-intervention
|
3.68 score on a scale
Standard Deviation 2.00
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Telling_Internal States Terms_1month follow-up
|
5.21 score on a scale
Standard Deviation 3.20
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Telling_Comprehension Questions_Pre-intervention
|
6.50 score on a scale
Standard Deviation 1.79
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Telling_Comprehension Questions_1month follow-up
|
8.32 score on a scale
Standard Deviation 1.56
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Retelling_Story Structure_Pre-intervention
|
9.07 score on a scale
Standard Deviation 2.18
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Retelling_Story Structure_1month follow-up
|
12.21 score on a scale
Standard Deviation 2.28
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Retelling_Structural Complexity_Pre-intervention
|
2.32 score on a scale
Standard Deviation 0.58
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Retelling_Structural Complexity_1month follow-up
|
2.75 score on a scale
Standard Deviation 0.38
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Retelling_Internal States Terms_Pre-intervention
|
5.07 score on a scale
Standard Deviation 2.13
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Retelling_Internal States Terms_1month follow-up
|
6.14 score on a scale
Standard Deviation 1.56
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Retelling_Comprehension Questions_Pre-intervention
|
6.46 score on a scale
Standard Deviation 1.96
|
—
|
|
Multilingual Assessment Instrument for Narratives (MAIN)
Retelling_Comprehension Questions_1month follow-up
|
8.21 score on a scale
Standard Deviation 1.66
|
—
|
Adverse Events
rTMS Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rTMS Group
n=30 participants at risk
Participants will receive accelerated continuous theta burst stimulation (a-cTBS, i.e. triplet standard cTBS, 1800 pulses/120s) for a 5 consecutive days, at an intensity that is 80% of the resting motor threshold (RMT) . a-cTBS repeats ten times a day with about 50 min interval . If feasible for the participant, all stimulation sessions will be held at the same time of the day. Treatment will be applied in left primary motor cortext (M1).
repetitive Transcranial Magnetic Stimulation: A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
|
|---|---|
|
Nervous system disorders
agitation
|
20.0%
6/30 • A semi-structured interview was administered following each treatment session and 1 month follow-up.
rating the event as mild (no impairment, no need stopping trial), moderate (some impairment, need stopping trial, no need for intervention), severe (evidence of impairment, need stopping trial and need for intervention).
|
|
Skin and subcutaneous tissue disorders
scalp pain
|
10.0%
3/30 • A semi-structured interview was administered following each treatment session and 1 month follow-up.
rating the event as mild (no impairment, no need stopping trial), moderate (some impairment, need stopping trial, no need for intervention), severe (evidence of impairment, need stopping trial and need for intervention).
|
|
Nervous system disorders
nausea
|
3.3%
1/30 • A semi-structured interview was administered following each treatment session and 1 month follow-up.
rating the event as mild (no impairment, no need stopping trial), moderate (some impairment, need stopping trial, no need for intervention), severe (evidence of impairment, need stopping trial and need for intervention).
|
Additional Information
Fei Li
Shanghai Jiaotong University School of Medicine Xinhua Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place