Autism Spectrum DisorderNCT06362200
The Validation and Biological Index Studies on the Improved Social Function of ASD by 40 Hz tACS
A study testing 40 Hz tACS intervention in people with Autism Spectrum Disorder, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- 40 Hz tACS intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2024to 13 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- There is a serious neurological disorder, a clear family history or a potential risk.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychiatry, Xiangya Second Hospital, Central South University
Changsha, Hunan, 410000
About this study
Official title: The Validation and Biological Index Studies on the Improved Social Function of Autism Spectrum Disorder by 40 Hz Transcranial Alternating Current Stimulation
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.
Read the detailed description
The objective of this clinical study is to investigate the effects and mechanisms of transcranial alternating current stimulation (tACS) on neural modulation in the right temporoparietal junction (rTPJ) of autism spectrum disorders. The primary inquiry it seeks to address is the impact of tACS the treatment of autism spectrum disorders (ASD) through its influence on the rTPJ . Participants will undergo baseline assessments of clinical symptoms and cognitive levels, utilize electroencephalography (EEG) to monitor brain electrical activity during both resting and task states, analyze EEG neurophysiological characteristics, use eye tracking technology to collect data on participants' eye movements during cognitive tasks, employ functional magnetic resonance spectroscopy (fMRS) to detect neurotransmitters such as glutamate + glutamine (Glx), GABA+ macromolecules (GABA+) and taurine in resting state and Theory of Mind task, as well as utilize magnetic resonance imaging (MRI) to detect and analyze functional connectivity and synchronous activation of relevant brain regions during both resting state and task state. Following completion of baseline assessment and examination, participants will be randomly assigned into two groups: a 40 Hz tACS group and a sham stimulation group with 30 patients in each group for a total of 60 patients. Subjects in the tACS group will receive tACS intervention at 2.0mA with a frequency of 40Hz while subjects in the sham group will receive placebo stimulation at a similar location and frequency with no current between periods. Standardized assessment tools along with Theory of Mind tasks will be utilized to evaluate multidimensional changes in clinical symptoms and cognitive levels post-intervention. Additionally, EEG will again be used to monitor brain electrical activity during both resting and task states by analyzing functional E/I values (fE/I) as well as indicators of EEG oscillatory activity such as α- power, γ-power etc., Eye tracker data analysis will also be conducted again for changes in eye fixation during cognitive tasks while fMRS analysis will focus on changes in neurotransmitters. Furthermore, MRI analysis post-intervention aims to examine changes in functional connectivity along with synchronous activation within rTPJ region alongside related brain regions once more. Researchers aim to validate the efficacy \& safety profile associated with 40 Hz tACS intervention within rTPJ for treating social impairment observed within ASD population whilst exploring biological indicators \& mechanisms underlying effective treatment strategies involving 40 Hz tACS intervention program.
- Conditions
- Autism Spectrum Disorder
- Being tested
- 40 Hz tACS intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 Hz tACS interventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 40 Hz tACS intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline, the day after intervention, three weeks after intervention
Secondary outcomes (11)
EEG physiological detection index
detect resting state and task state EEG, analyze and calculate the functional E/I ratio of EEG power spectrum
Measured: At baseline, the day after intervention, three weeks after intervention
Magnetic resonance detection index
Functional magnetic resonance imaging (fMRI) data were used to analyze the functional status and network connectivity between rTPJ and other brain regions. Glx, GABA+, taurine and other neurotransmitters were detected by magnetic resonance spectroscopy to evaluate the changes in the key transmitters of neural E/I balance.
Measured: At baseline, the day after intervention, three weeks after intervention
Eye movement index
Eye tracker was used to record the visual movement trajectories of the subjects when they were performing cognitive tasks, and these movement patterns were analyzed to understand the subjects' attention concentration points and emotional responses in different task situations.
Measured: At baseline, the day after intervention, three weeks after intervention
Emotion recognition index
The "Reading the Mind in the Eyes" test is a psychological assessment to measure subject's ability to understand or infer the mental states of others through the observation of their eyes. It's used to investigate social cognition, empathy, and theory of mind.
Measured: At baseline, the day after intervention, three weeks after intervention
Understanding of social interaction index
The Frith-Happe animations task is used to measure individuals' ability to understand and interpret social interactions. In this task, participants are shown 8 short animated video clips depicting simple social interactions between triangle shapes. Participants will be asked whether the type of interaction of triangles in these animations is random or psychological, and be rated according to their choice of the type of interaction presented by the triangle animation. Each animation gets one point if it chooses the interaction type correctly; otherwise, it gets zero points. The total score is eight.
Measured: At baseline, the day after intervention, three weeks after intervention
Understanding of thoughts and intentions index
Strange Stories Task involves presenting participants with a series of short narrative vignettes that involve interactions between characters that require the reader to infer the characters' thoughts, beliefs, intentions, and emotions. After reading each story, participants are asked questions or prompted to make judgments about the characters' mental states, motivations, and interpretations. Responses are then scored based on the participant's ability to accurately interpret the social cues presented in the narratives. Each question is scored 0, 1, and 2 according to the scoring standard.
Measured: At baseline, the day after intervention, three weeks after intervention
Social Communication Changes index
Assessed by the Social Response Scale (SRS-II). The change in social communication scores from baseline to the end of the study period will be the primary outcome of interest, the critical value is 59.5, and the total score is the sum of all entries, with the lowest score of 0 and the highest score of 3 for each entry.
Measured: At baseline, the day after intervention, three weeks after intervention
Stereotyped behavior index
The Repetitive Stereotyping Behavior Scale-Revised (RBS-R) is a tool used to assess repetitive and stereotyping behaviors in autism spectrum disorders (ASD) and other related disorders. The scale consists of 5 subscales, namely Ⅰ stereotypical behavior scale, Ⅱ self-injury behavior scale, Ⅲ impulsive behavior scale, Ⅳ ritualistic behavior scale, Ⅴ fixed behavior scale, and the score is 0= these behaviors have never happened -- 3= these behaviors have happened. And it's serious; The number of positive items is items other than those with a zero score.
Measured: At baseline, the day after intervention, three weeks after intervention
Sensory index
The Short Sensory Profile (SSP) was used to assess sensory processing abnormalities in children. Each statement has a rating range, which is a 5-point scale from "always" to "never." Raters need to rate the child based on how often they respond to specific sensory inputs. The total score of the SSP is the sum of the scores of all entries. The lowest score generally reflects a higher level of sensory processing difficulty, while the highest score indicates less difficulty.
Measured: At baseline, the day after intervention, three weeks after intervention
Abnormal behavior indicator
Individuals are assessed for behavioral abnormalities using the Aberrant Behavior Checklist-Second Edition (ABC-II), a scoring system designed according to the frequency and severity of behavioral problems. For each entry, raters are asked to rate it according to the following criteria: 0: no problem at all. Score 1: The behavior is problematic, but the degree is not serious. Score 2: The problem is moderately serious. 3 marks: The problem is serious. The total score for ABC-II is the sum of scores for all entries, with the lowest score (i.e., all entries are rated 0) indicating that no behavioral problems were observed, while the highest score (i.e., all entries are rated 3) indicating widespread and serious behavioral problems.
Measured: At baseline, the day after intervention, three weeks after intervention
Sleep index
Childhood Sleep Disorders Scale (SDSC) was used to assess children's sleep problems and habits. Ratings are usually based on frequency and duration, such as "always," "often," "sometimes," "occasionally," or "never happens." Each entry is typically scored on a scale of 0 to 5, with 0 being no problem and the highest being the most serious. The total score of the CSHQ is the sum of the scores of all entries.
Measured: At baseline, the day after intervention, three weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start7 Apr 2024
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Jun Ou, Central South University
- Investigators
- Jianjun Ou, doctor, Study chair, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362200
- Sponsor's protocol ID
- LYG20230083
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validation and Biological Index Studies on the Improved Social Function of Autism Spectrum Disorder by 40 Hz Transcranial Alternating Current Stimulation
- ClinicalTrials.gov ID
- NCT06362200
- Acronym / sponsor ID
- LYG20230083
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this clinical study is to investigate the effects and mechanisms of transcranial alternating current stimulation (tACS) on neural modulation in the right temporoparietal junction (rTPJ) of autism spectrum disorders. The primary inquiry it seeks to address is the impact of tACS the treatment of autism spectrum disorders (ASD) through its influence on the rTPJ . Participants will undergo baseline assessments of clinical symptoms and cognitive levels, utilize electroencephalography (EEG) to monitor brain electrical activity during both resting and task states, analyze EEG neurophysiological characteristics, use eye tracking technology to collect data on participants' eye movements during cognitive tasks, employ functional magnetic resonance spectroscopy (fMRS) to detect neurotransmitters such as glutamate + glutamine (Glx), GABA+ macromolecules (GABA+) and taurine in resting state and Theory of Mind task, as well as utilize magnetic resonance imaging (MRI) to detect and analyze functional connectivity and synchronous activation of relevant brain regions during both resting state and task state. Following completion of baseline assessment and examination, participants will be randomly assigned into two groups: a 40 Hz tACS group and a sham stimulation group with 30 patients in each group for a total of 60 patients. Subjects in the tACS group will receive tACS intervention at 2.0mA with a frequency of 40Hz while subjects in the sham group will receive placebo stimulation at a similar location and frequency with no current between periods. Standardized assessment tools along with Theory of Mind tasks will be utilized to evaluate multidimensional changes in clinical symptoms and cognitive levels post-intervention. Additionally, EEG will again be used to monitor brain electrical activity during both resting and task states by analyzing functional E/I values (fE/I) as well as indicators of EEG oscillatory activity such as α- power, γ-power etc., Eye tracker data analysis will also be conducted again for changes in eye fixation during cognitive tasks while fMRS analysis will focus on changes in neurotransmitters. Furthermore, MRI analysis post-intervention aims to examine changes in functional connectivity along with synchronous activation within rTPJ region alongside related brain regions once more. Researchers aim to validate the efficacy \& safety profile associated with 40 Hz tACS intervention within rTPJ for treating social impairment observed within ASD population whilst exploring biological indicators \& mechanisms underlying effective treatment strategies involving 40 Hz tACS intervention program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 Hz tACS group | Experimental | Device: 40 Hz tACS intervention40 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. |
| control group | Placebo comparator | Device: 40 Hz tACS interventionthe 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- There is a serious neurological disorder, a clear family history or a potential risk.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 Hz tACS interventionThe 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. | Device | 40 Hz tACS group, control group |
Primary outcome
Autism assessment assessment index
Time frame: At baseline, the day after intervention, three weeks after intervention
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).
11 secondary outcomes
EEG physiological detection index
Time frame: At baseline, the day after intervention, three weeks after intervention
Magnetic resonance detection index
Time frame: At baseline, the day after intervention, three weeks after intervention
Eye movement index
Time frame: At baseline, the day after intervention, three weeks after intervention
Emotion recognition index
Time frame: At baseline, the day after intervention, three weeks after intervention
Understanding of social interaction index
Time frame: At baseline, the day after intervention, three weeks after intervention
Understanding of thoughts and intentions index
Time frame: At baseline, the day after intervention, three weeks after intervention
Social Communication Changes index
Time frame: At baseline, the day after intervention, three weeks after intervention
Stereotyped behavior index
Time frame: At baseline, the day after intervention, three weeks after intervention
Sensory index
Time frame: At baseline, the day after intervention, three weeks after intervention
Abnormal behavior indicator
Time frame: At baseline, the day after intervention, three weeks after intervention
Sleep index
Time frame: At baseline, the day after intervention, three weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianjun Ou, doctor study chair
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40 Hz tACS intervention in people with Autism Spectrum Disorder, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism assessment assessment index (time frame: At baseline, the day after intervention, three weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.