Trial Outcomes & Findings for The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder (NCT NCT03621189)
NCT ID: NCT03621189
Last Updated: 2024-01-23
Results Overview
Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)
Results posted on
2024-01-23
Participant Flow
Of the total 80 patients, 5 withdrew from the study.
Participant milestones
| Measure |
Active-Active
Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
Sham-Active
Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Active-Active
Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
Sham-Active
Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active-Active
n=40 Participants
Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
Sham-Active
n=35 Participants
Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13 years
STANDARD_DEVIATION 2.8 • n=40 Participants
|
12.5 years
STANDARD_DEVIATION 2.9 • n=35 Participants
|
12.8 years
STANDARD_DEVIATION 2.9 • n=75 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=40 Participants
|
5 Participants
n=35 Participants
|
10 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=40 Participants
|
30 Participants
n=35 Participants
|
65 Participants
n=75 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Full scale intelligence
|
88.2 units on a scale
STANDARD_DEVIATION 16.7 • n=40 Participants
|
90 units on a scale
STANDARD_DEVIATION 14.7 • n=35 Participants
|
89 units on a scale
STANDARD_DEVIATION 15.8 • n=75 Participants
|
|
Social Responsiveness Scale
|
107.3 units on a scale
STANDARD_DEVIATION 24 • n=40 Participants
|
102.1 units on a scale
STANDARD_DEVIATION 23.2 • n=35 Participants
|
104.9 units on a scale
STANDARD_DEVIATION 23.8 • n=75 Participants
|
|
Repetitive Behavior Scale-Revised
|
32.2 units on a scale
STANDARD_DEVIATION 18.9 • n=40 Participants
|
33.5 units on a scale
STANDARD_DEVIATION 20.6 • n=35 Participants
|
32.8 units on a scale
STANDARD_DEVIATION 19.7 • n=75 Participants
|
|
Eye task
|
20.8 units on a scale
STANDARD_DEVIATION 8 • n=40 Participants
|
24.8 units on a scale
STANDARD_DEVIATION 6.9 • n=35 Participants
|
22.7 units on a scale
STANDARD_DEVIATION 7.8 • n=75 Participants
|
|
Frith-Happe Animation (Total)
|
5.5 units on a scale
STANDARD_DEVIATION 2.1 • n=40 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.9 • n=35 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 2 • n=75 Participants
|
|
Comorbidity with ADHD
|
22 Participants
n=40 Participants
|
14 Participants
n=35 Participants
|
36 Participants
n=75 Participants
|
|
Medication (Methylphenidate)
|
14 Participants
n=40 Participants
|
10 Participants
n=35 Participants
|
24 Participants
n=75 Participants
|
|
Medication (Atomoxetine)
|
1 Participants
n=40 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=75 Participants
|
|
Medication (Antipsychotics)
|
5 Participants
n=40 Participants
|
5 Participants
n=35 Participants
|
10 Participants
n=75 Participants
|
PRIMARY outcome
Timeframe: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.
Outcome measures
| Measure |
Active-Active
n=40 Participants
Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
Sham-Active
n=35 Participants
Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
|---|---|---|
|
Changes of Total Scores of Social Responsiveness Scale
Baseline
|
107.3 score on a scale
Standard Deviation 24
|
102.1 score on a scale
Standard Deviation 23.2
|
|
Changes of Total Scores of Social Responsiveness Scale
During TBS
|
103.4 score on a scale
Standard Deviation 25.5
|
100.1 score on a scale
Standard Deviation 27.1
|
|
Changes of Total Scores of Social Responsiveness Scale
Post TBS
|
98.5 score on a scale
Standard Deviation 28.7
|
95.1 score on a scale
Standard Deviation 25.7
|
|
Changes of Total Scores of Social Responsiveness Scale
One month follow up
|
97.2 score on a scale
Standard Deviation 25.6
|
94.7 score on a scale
Standard Deviation 27.9
|
PRIMARY outcome
Timeframe: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)RBS-R is a questionnaire that focuses on repetitive behavior. The score range from 0-129. The lower scores stand for lower repetitive behavior.
Outcome measures
| Measure |
Active-Active
n=40 Participants
Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
Sham-Active
n=35 Participants
Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
|---|---|---|
|
Changes of Total Scores of Repetitive Behavior Scale-Revised
Baseline
|
32.2 score on a scale
Standard Deviation 18.9
|
33.5 score on a scale
Standard Deviation 20.6
|
|
Changes of Total Scores of Repetitive Behavior Scale-Revised
During TBS
|
28.9 score on a scale
Standard Deviation 20.1
|
28.1 score on a scale
Standard Deviation 21.5
|
|
Changes of Total Scores of Repetitive Behavior Scale-Revised
Post TBS
|
25.9 score on a scale
Standard Deviation 20.5
|
31.5 score on a scale
Standard Deviation 23.9
|
|
Changes of Total Scores of Repetitive Behavior Scale-Revised
One month follow up
|
24.3 score on a scale
Standard Deviation 17.6
|
29 score on a scale
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition (The score ranges from 0-48).
Outcome measures
| Measure |
Active-Active
n=40 Participants
Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
Sham-Active
n=35 Participants
Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
|---|---|---|
|
Changes in Accuracy of Frith-Happe Animation
Post TBS
|
5.4 score on a scale
Standard Deviation 2
|
5.4 score on a scale
Standard Deviation 2.3
|
|
Changes in Accuracy of Frith-Happe Animation
One month follow up
|
5.4 score on a scale
Standard Deviation 2.1
|
5.2 score on a scale
Standard Deviation 2.6
|
|
Changes in Accuracy of Frith-Happe Animation
Baseline
|
5.5 score on a scale
Standard Deviation 2.1
|
5.6 score on a scale
Standard Deviation 1.9
|
|
Changes in Accuracy of Frith-Happe Animation
During TBS
|
5.4 score on a scale
Standard Deviation 1.8
|
5.7 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills (The score ranges from 0-43).
Outcome measures
| Measure |
Active-Active
n=40 Participants
Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
Sham-Active
n=35 Participants
Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
|---|---|---|
|
Changes in Accuracy of Eyes Task
Baseline
|
20.8 score on a scale
Standard Deviation 8
|
24.8 score on a scale
Standard Deviation 6.9
|
|
Changes in Accuracy of Eyes Task
During TBS
|
21.9 score on a scale
Standard Deviation 8.1
|
25.8 score on a scale
Standard Deviation 7
|
|
Changes in Accuracy of Eyes Task
Post TBS
|
21.8 score on a scale
Standard Deviation 9
|
24.8 score on a scale
Standard Deviation 6.3
|
|
Changes in Accuracy of Eyes Task
One month follow up
|
22 score on a scale
Standard Deviation 8.6
|
26 score on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)The MRI data have to be pre-processed before analysis. It may take few years.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)The MRI data have to be pre-processed before analysis. It may take few years.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline)The MRI data have to be pre-processed before analysis. It may take few years.
Outcome measures
Outcome data not reported
Adverse Events
Active-Active
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham-Active
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active-Active
n=40 participants at risk
Participants received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 8 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
Sham-Active
n=35 participants at risk
Participants received the sham intervention of TBS (coil tilted one-wing 90° off the head) over the posterior superior temporal sulcus for 4 weeks (2 days/week) and then received the real intervention of TBS (iTBS 1200) over the posterior superior temporal sulcus for 4 weeks (2 days/week).
\*iTBS = intermittent theta burst stimulation
|
|---|---|---|
|
Nervous system disorders
Pain at application site
|
10.0%
4/40 • The adverse event would be assessed before and after intervention every session, up to 4 weeks.
|
28.6%
10/35 • The adverse event would be assessed before and after intervention every session, up to 4 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place