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The problem
Intervention: Bilateral deep brain stimulation targeting the nucleus accumbens (NAc-DBS)
Who it was tested with: 25 children with autism spectrum disorder and severe, refractory self-injurious behaviour.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"A single-centre, randomised double-blinded, crossover trial is proposed. Informed by the results of our pilot study, 25 subjects with autism spectrum disorder and severe, refractory SIB will undergo bilateral NAc-DBS." The design uses randomisation and blinding to reduce bias and a crossover structure to allow within-subject comparison of stimulation ON versus OFF conditions.
This is a protocol for a planned trial, not completed research with results. The findings reported are from a preliminary phase I trial only.
Across countries and designs
1 study · 0 countries
