The Validation and Biological Index Studies on the Improved Social Function of ASD by 40 Hz tACS

NCT06362200 | Completed

• 1 other identifier: LYG20230083
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

In this proposed study, tACS will be used to intervene in the autism spectrum disorders of children and adolescents, and the efficacy of this intervention method will be evaluated, as well as the internal mechanism of adolescents' autism spectrum disorders will be discussed.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Autism assessment assessment index

  Autism was assessed using the Oregon State University Autism Rating Scale, DSM-5 (OARS-5), which includes the signs and symptoms of autism spectrum disorders described in the DSM-5. The scores include :1; Total number of symptoms. Every symptom that occurs (i.e., 1, 2, or 3 points) is recorded in the symptom count. 2. Weighted average severity. The clinician scored each item on a scale of 0, 1, 2 or 3 based on the parent's description of the particular problem. 3. Damage index. In Section C of OARS-5, after discussion with the child/adolescent's caregiver, the clinician will rate the level of support on a scale of 0(no support) to 3(maximum support).

  At baseline, the day after intervention, three weeks after intervention

Secondary Outcomes (11)

• EEG physiological detection index

  At baseline, the day after intervention, three weeks after intervention

• Magnetic resonance detection index

  At baseline, the day after intervention, three weeks after intervention

• Eye movement index

  At baseline, the day after intervention, three weeks after intervention

• Emotion recognition index

  At baseline, the day after intervention, three weeks after intervention

• Understanding of social interaction index

  At baseline, the day after intervention, three weeks after intervention

Other Outcomes (2)

• Plasma Metabolite Levels Assessment

  At baseline, the first day of intervention

• Safety evaluation SAFTEE indicator

  At baseline, the day after intervention, three weeks after intervention

Study Arms (2)

40 Hz tACS group

EXPERIMENTAL

40 Hz tACS group participants will receive tACS intervention stimulation (40Hz, 2.0mA, 20 minutes per session, three times a day, 21 times in total) for 1 week.

Device: 40 Hz tACS intervention

control group

PLACEBO COMPARATOR

the control group will be given the same frequency of pseudo-stimulation (0mA, 20 minutes per session, three times a day, 21 times in total) for 1 week.

Device: 40 Hz tACS intervention

Interventions

40 Hz tACS intervention DEVICE

The central electrode is placed in the CP6 and the other four electrodes are placed around the CP6. 40 Hz tACS group participants will receive alternating current stimulation (40Hz, 2.0mA, 20min/time, three times a day, 21 times in total) for 1 week. Subjects in the placebo comparator group will receive sham tACS for 1 week, which mimics the tACS intervention in terms of electrode placement and session frequency. However, the device will deliver a 0mA current, ensuring no actual stimulation occurs.

40 Hz tACS group; control group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 6-18 years old.
• has been clinically diagnosed with autism spectrum disorder by a psychiatrist
• Meet the diagnostic criteria for ASD recommended by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• Consistent with the diagnosis of ASD by used the Autism Diagnostic Interview Tool - Revised Edition (ADI-R) and the Autism Diagnostic Observation Tool (ADOS) assessment.
• Can cooperate with transcranial alternating current stimulation.

You may not qualify if:

• b) There is a serious neurological disorder, a clear family history or a potential risk.
• c) There are metal implants in the brain, holes or cracks in the skull. e) The presence of a definite or suspected genetic disorder.
• the presence of common genetic disorders, such as trisomy 21 syndrome
• The presence of serious physical diseases, such as significant intracranial lesions, thyroid disease, epilepsy, congenital heart disease, severe blood system diseases, systemic lupus erythematosus, audio-visual impairment, etc.
• meet the diagnosis of other major mental disorders, such as schizophrenia and bipolar disorder.
• Imaging examination reveals obvious abnormalities in brain structure.
• Currently taking or have taken benzodiazepine medications or antiepileptic drugs within the past week.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Department of Psychiatry, Xiangya Second Hospital, Central South University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jianjun Ou, doctor

  Central South University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 12, 2024
• Study Start: April 7, 2024
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2025
• Last Updated: June 10, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)