Autism spectrum disorders
Conditions
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
7 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Children and adolescents aged 7 to 18 years, of any gender. 2.Those meeting the diagnosis of Autism Spectrum Disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 3.With a duration of illness of at least 5 years, having received ineffective systematic behavioral interventions or training, or being unable to undergo training. 4.Having received multiple drug treatments (including one or more antipsychotic drugs and one or more mood stabilizers) with poor efficacy. 5. Scored =37 on the Childhood Autism Rating Scale (CARS) during the screening and baseline periods; 6. Scored =4 on the Clinical Global Impression-Severity (CGI-S) during the screening and baseline periods; 7.Guardians who have been fully informed about the research objectives, content, expected treatment, and risks, and who consent to the subject receiving treatment with an implanted neural stimulation system, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients who do not meet the diagnostic criteria for Autism Spectrum Disorder according to DSM-5. 2.Patients with substance dependence in the past 6 months, excluding tobacco. 3.Those with severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, endocrine, neurological, or other systemic diseases. 4.Individuals who have undergone cochlear implantation, cardiac pacemaker implantation, implantable cardioverter defibrillator implantation, those who have previously implanted similar products unilaterally or bilaterally, or those who have undergone other surgical procedures within the past six months that the investigator considers to affect this trial. 5.Those currently participating in or who have participated in other drug or medical device clinical trials within the past 3 months before screening. 6.Individuals deemed unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Autism Behavior Checklist (AuBC) scores from baseline to six months after system activation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in Autism Behavior Checklist (AuBC) scores from baseline to three months after system activation;The change in Childhood Autism Rating Scale (CARS) scores from baseline to the end of the third month and the end of the sixth month after system activation;The change in Aberrant Behavior Checklist (AbBC) scores from baseline to the end of the third month and the end of the sixth month after system activation;The change values of the Family Assessment Device (FAD) scores compared to baseline at the end of the third and sixth months after startup.;The change values of the Pediatric Quality of Life Inventory (PedsQL 4.0) scores compared to baseline at the end of the third and sixth months after startup.;The change values of the Autism Treatment Evaluation Checklist (ATEC) scores compared to baseline at the end of the third and sixth months after startup.;The change values of the Repetitive Behavior Scale-Revised (RBS-R) scores compared to baseline at the end of the third and sixth months after startup.;The change values of the Global Assessment of Functioning (GAF) scores compared to baseline at the end of the third and sixth months after startup.;The change values of the Clinical Global Impressions (CGI) scores compared to baseline at the end of the third and sixth months after startup; | — |
Countries
China
Contacts
Public ContactLiang Chen
Huashan Hospital, Fudan University
Outcome results
None listed