autism
Conditions
Interventions
Single unit:(nucleus accumbens - forelimb of internal capsule) dual-target deep brain stimulation
Sponsors
The 900th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
Eligibility
Sex/Gender
All
Age
7 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Male or Female patients between age 7 to 18; 2.Meets the diagnosis of Autism Spectrum Disorder (ASD) as defined by the DSM-5; 3.Condition or disease duration >= 5 years, and patients have received systematic behavioral therapies or training that have been ineffective, or cannot tolerate the training; 4.The legal guardian agrees to the patient's treatment with DBS in the nucleus accumbens (NAc) and anterior limb of the internal capsule (ALIC) and signs an informed consent form after being fully informed of the description of the purpose and content of the study, the intended treatment, and the risks.
Exclusion criteria
Exclusion criteria: 1. Patients with substance dependence in the past 6 months, except tobacco; 2. Patients with severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, endocrine, neurological, or other systemic disorders; 3. Patients who have had a cochlear implant, pacemaker, cardiac defibrillator, have had a unilateral or bilateral implant of the same type, or have had any other surgical procedure within six months that in the opinion of the investigator would have an effect on the trial; 4. Patients who are currently participating in or have participated in a clinical trial of another drug or medical device within 3 months prior to screening; 5.Other patients who, in the opinion of the investigator, are not suitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Autism Behavior Checklist (AuBC) scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Autism Behavior Checklist (AuBC) scores at the end of 1 and 3 months after DBS-ON compared to baseline values;Changes in Childhood Autism Rating Scale (CARS) scores at the end of 1, 3, and 6 months after DBS-ON compared to baseline values;Changes in Repetitive Behaviors Scale - Revised (RBS-R) scores at the end of 1, 3, and 6 months after DBS-ON compared to baseline values;Changes in Aberrant Behavior Checklist (AbBC) scores at the end of 1, 3, and 6 months after DBS-ON compared to baseline values;Changes in Autism Treatment Evaluation Checklist (ATEC) scores at the end of 1, 3, and 6 months after DBS-ON compared to baseline values;Changes in Clinical Global Impression Scale - Severity (CGI-S) scores at the end of 1, 3, and 6 months after DBS-ON compared to baseline values;Changes in Clinical Global Impression Scale - Improvement (CGI-I) scores at the end of 1, 3, and 6 months after DBS-ON compared to baseline values;Changes in Global Assessment of Functioning (GAF) scores at the end of 1, 3, and 6 months after DBS-ON compared to baseline values;Changes in social and behavioral activities of the patients compared to baseline were evaluated by video at the end of 1, 3, and 6 months after DBS-ON; | — |
Countries
China
Contacts
Public ContactBangqing Yuan
The 900th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
Outcome results
None listed