Autism Spectrum Disorder
Conditions
Brief summary
The goal of this single-blinded, randomized controlled trial is to assess the safety, tolerability, and feasibility of tTIS for children with ASD. The main question it aims to answer is: \- Is tTIS safe, tolerable, and feasible for use for children with autism spectrum disorder? Researchers will compare tTIS group with control group to explore the safety and feasibility of the transcranial electrical stimulation for children with autism. Participants will: * tTIS group: undergo 5 days of temporal tTIS. * Sham group: undergo 5 days of temporal tTIS without low-frequency envelope. From baseline to 4 weeks after intervention completion, subjects will be followed up regarding clinical symptoms and adverse events: * Primary Outcome Measures: Safety and feasibility of tTIS, assessed by adverse events, treatment completion rate, adherence to the stimulation protocol and tolerability. * Secondary/Exploratory Outcome Measures: Changes in SRS-2 total scores and other clinical measures related to language, adaptive functioning, and cognition.
Detailed description
This research is a 5-week single-blinded, randomized controlled trial, planning to enroll 16 ASD children aged 4-10 with a full-scale intelligence quotient (FSIQ) of 50 or above. Children who satisfy all inclusion criteria without meeting any exclusion criteria, may be enrolled after their legal guardians provided the written informed consent. Eligible subjects will be randomly divided into two groups: tTIS group and sham group. The tTIS group will undergo 5 days of temporal TI stimulation (1.5mA, 2040/2000Hz, 20min/session, 6 sessions/day); the control group will undergo 5 days of temporal TI stimulation (1.5mA, 2000/2000Hz, 20min/session, 6 sessions/day, without 40Hz envelope compared to tTIS group) At baseline, subjects will undergo physical measurements, demographic and medical history collection, intelligence test and symptom clinical scale assessments, and resting-state EEG collection. From the start of intervention until 4 weeks after completion, subjects will be followed up regarding clinical symptoms, neuroimaging, and adverse events. Primary Outcome Measures: \- Safety and feasibility of tTIS, assessed by adverse events, treatment completion rate, adherence to the stimulation protocol and tolerability. Secondary outcomes: * Change in Social Responsiveness Scale, Second Edition (SRS-2) total score from baseline to immediately after completion of the 5-day intervention. * Change in SRS-2 total score from baseline to 4 weeks after completion of the 5-day intervention. * Changes in other clinical measures from baseline to 4 weeks after completion of the 5-day intervention, including the Chinese Communicative Development Inventory (CCDI), Childhood Autism Rating Scale (CARS), Peabody Picture Vocabulary Test (PPVT), selected subtests of A Developmental Neuropsychological Assessment, Second Edition (NEPSY-II; Narrative Memory, Memory for Faces, Theory of Mind, Word Generation, and Affect Recognition), and Clinical Global Impression (CGI) scale scores. Exploratory Outcomes: \- resting-state and task-state EEG neuroimaging characteristics before intervention, immediately after the 5-day intervention, and 4 weeks after completion of the 5-day intervention
Interventions
Receive tTIS targeting the anterior middle temporal gyrus with stimulation frequency of 2040/2000HZ, using battery power supply: voltage 12V, current set at 1.5mA, 6 times/day, 20min/session with 20min intervals between sessions, lasting for 5 days.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 4-10 years * Meeting the diagnostic criteria for ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and confirmed by the Autism Diagnostic Observation Schedule (ADOS) and/or the Autism Diagnostic Interview-Revised (ADI-R) * Full Scale Intelligence Quotient (FSIQ) ≥50 * Signed informed consent form
Exclusion criteria
* Individuals with metal implants in the body * Individuals with neurological disorders such as epilepsy * Those requiring surgical treatment due to structural abnormalities indicated by brain MRI examination * Those diagnosed with genetic or chromosomal abnormalities * Individuals with mental illness (such as early-onset schizophrenia) * Those with severe cardiac disease * Individuals with increased intracranial pressure * Those currently participating in other clinical trials * Those who received new intervention protocols within 4 weeks prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of the tTIS intervention protocol | During the 5-day intervention | The proportion of participants who complete all scheduled tTIS sessions according to the predefined stimulation protocol during the 5-day intervention. |
| Number of participants with adverse events | From the start of the intervention to 4 weeks after completion of the 5-day intervention. | The number and proportion of participants who experience adverse events during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SRS-2 | Baseline, after completion of 5-day intervention | Change from baseline in SRS-2 score immediately after the 5-day intervention. The SRS-2 is primarily used to assess symptoms associated with ASD. Compared to other autism assessment tools, the SRS-2 stands out for its focus on quantifying the severity of social impairment, with higher scores indicating more autism symptoms and greater social disability. |
| Childhood Autism Rating Scale (CARS) | Baseline, 4 weeks after completion of 5-day intervention | Change in CARS score from baseline to 4 weeks after the 5-day intervention. CARS is a behavior rating scale used to assess the presence and severity of the symptoms associated autism spectrum disorder. The scores of the CARS rate from 15 to 60, and higher scores indicate more severe symptoms. The changes in the CAR scores from baseline to 3 months after the treatment will be analyzed to asses the impact often intervention on participants with ASD. |
| Social Responsiveness Scale, Second Edition (SRS-2) | Baseline, 4 weeks after completion of 5-day intervention | Change in SRS-2 score from baseline to 4 weeks after completion of the 5-day intervention.The SRS-2 is primarily used to assess symptoms associated with ASD. Compared to other autism assessment tools, the SRS-2 stands out for its focus on quantifying the severity of social impairment, with higher scores indicating more autism symptoms and greater social disability. |
| Chinese Communicative Development Inventory, CCDI | Baseline, 4 weeks after completion of 5-day intervention | Change in CCDI score from baseline to 4 weeks after the 5-day intervention.Chinese Communicative Development Inventory(CCDl) is a questionnaire used to measures the language abilities. Higher scores suggest better language level. The changes in the CCDl between baseline and 3 month after treatment will be analyzed. |
| Peabody Picture Vocabulory Test, PPVT | Baseline, 4 weeks after completion of 5-day intervention | Change in PPVT score from baseline to 4 weeks after the 5-day intervention. PPVT as a tool for measuring children's language receptive ability and language comprehension ability. |
| Neuropsychological Assessment for Child, NEPSY-II | Baseline, 4 weeks after completion of 5-day intervention | Change in NEPSY-II score from baseline to 4 weeks after the 5-day intervention. NEPSY-II is a comprehensive neuropsychological measurement tool used for assessing neuro-cognitive functions in children aged 3-16 years. This study primarily evaluates the following aspects: narrative memory assessment, facial memory assessment, theory of mind, word generation, affection recognition. |
| Vineland Adaptive Behavior Scales-Third Edition, Vineland-3 | Baseline, 4 weeks after completion of 5-day intervention | Change in VABS-3 score from baseline to 4 weeks after the 5-day intervention. The VABS-3 is used to measure adaptive functioning across domains such as communication,daily living skills, socialization, and motor skills. Changes in VABs scores from baseline to 3 months post-treatment will be analyzed to assess the intervention's impact on adaptive behaviors in children with ASD. |
| Clinical Global Impression Scale (CGI) | after completion of 5-day intervention, four weeks after completion of 5-day intervention | The Clinical Global Impressions (CGI) scale is used to assess both the severity of illness and the global improvement of participants undergoing intervention. |
| Multilingual Assessment Instrument for Narratives (MAIN) | Baseline, 4 weeks after completion of 5-day intervention | Change in MAIN score from baseline to 4 weeks after the 5-day intervention. MAIN assess narrative comprehension and production skills of children who exhibited a certain level of expressive ability (at least can use flexible phrases). In this test, children tell or retell the stories and answer some questions, with assessors evaluating performance. Higher scores suggest better language level. |
Countries
China
Outcome results
None listed