An open-label prospective pilot trial of nucleus accumbens deep brain stimulation for children with autism spectrum disorder and severe, refractory self-injurious behavior: study protocol

Table 3 Follow-up schedule for trial participan ts

		Study period
		Enrollment	Surgery	Follow-up					Post-trial
Timepoint		Week 8 ± 4 weeks	Baseline W0	Weekly (W1–6) ± 1 day	Every 4 W (W8–56) ± 3 days	Week 12 ± 1 week	Week 26 ± 2 weeks	Week 52 ± 2 weeks	W > 52
Enrollment	Eligibility screen	X
	Informed consent for trial	X
	Demographics questionnaire	X
	Anesthetic evaluation	X
	Informed surgical consent	X
In-hospital treatment and care	Deep brain stimulation leads and IPG insertion		X
In-hospital treatment and care	Programming				X	X	X	X	Every 6 months or as indicated
Imaging	MRI	X (or earlier)	X
	CT		X
	FDG-PET (optional)	X						X
Questionnaires	Children’s Yale-Brown Obsessive-Compulsive Scale in ASD (CYBOCS-ASD)	X		X (week 4)		X	X	X
	Inventory of Statements about Self-Injury (ISAS)	X		X (week 4)		X	X	X
	Behavior problems inventory (BPI)	X		X (week 4)		X	X	X
	Repetitive Behavior Scale-Revised (RBS-R)	X		X (week 4)		X	X	X
	Quality of Life Scale 9Peds QL	X		X (week 4)		X	X	X
	Aberrant Behavior Checklist	X		X (week 4)		X	X	X
Other assessments	Neurosurgery evaluation			X (virtual)	X (virtual)	X	X	X	Annual follow-up
	Neuropsychology evaluation	X					X	X	As needed
	Actigraphy (optional)	X				X		X
	Self-injury log	X		X	X	X	X	X

ISSN: 2055-5784