Table 2 Study inclusion and exclusion criteria
Inclusion criteria | |
 1. Children and adolescents between age 7-18 | |
 2. Diagnosed with autism spectrum disorder by a treating developmental pediatrician | |
 3. Failure or non-eligibility of medical therapy with ongoing repetitive self-injurious behaviors, at 6 months or more after instigation of therapy. Failure is defined as a lack of improvement in self-injurious behaviors, as documented by objective evidence, including caregiver logs or clinician assessment, if the clinician has documented a baseline status prior to instigation of the medical therapy. | |
 4. The child has undergone rigorous, gold-standard Functional Behavior Assessment including functional analysis, leading to treatment lasting a minimum of 6 months, without significant change from baseline. | |
 5. Diagnosis of secondary stereotypies, based on clinical assessment of the treating physicians with evidence of self-injury, documented in the patient records. The definition of self-injury is contextual, but requires current, previous or potential manifestation of physical injury to the child. | |
 6. The child is at risk of permanent injury as a result of self-injurious behaviors. Permanent injury is non-reversible physical injury causing a reduction in baseline functions. | |
 7. Parents or legal guardians, including caregivers, informed, and able to give written consent. | |
 8. Able to comply with all testing, follow-ups and study appointments and protocols for 12 months following the end of the duration of the study. | |
Exclusion criteria | |
 1. Does not meet study specific definition of autism spectrum disorder using DSM-5 criteria. The treating physicians at each individual clinic will be responsible for diagnosis. | |
 2. Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine | |
 3. Any contraindication to MRI, required for stereotactic surgical planning. | |
 4. Likely to relocate away from the study site or move during the study’s 1-year duration | |
 5. Presence of cardiac arrhythmias, coagulopathy or other cardiac, respiratory, renal, or endocrine conditions that will result in significant risk from a surgical procedure. | |
 6. Pregnancy |