Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorThe Hospital for Sick Children
About this trial
Deep Brain Stimulation for the Treatment of Severe Refractory Self-Injurious Behaviour in Children with Autism Spectrum Disorder: A Randomized Trial
To evaluate the effectiveness of deep brain stimulation (DBS) of the nucleus accumbens for the treatment of severe refractory, repetitive self-injurious behavior (SIB) in children with Autism Spectrum Disorder. Secondary objectives are to examine the effects of DBS on subtypes of SIB through functional analysis.
Eligibility criteria
Qualifiers
Age 5-17 at the time of enrollment
DSM-5 diagnosis of Autism Spectrum Disorder
History of repetitive self-injurious behaviour, as reported by parents and documented on clinical assessment, either at the time of enrollment into the study or in prior medical records. The definition of self-injury is contextual, but requires ongoing, intermittent or continuous manifestation of self-mediated physical injury to the child.
Foreseeable risk of serious future self-harm.
Disqualifiers
Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine.
Any contraindication to MRI scanning.
Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that may incur significant risk from a surgical procedure.
Pregnancy.
Trial design
Treatments tested in this trial
- DBS ON
- DBS OFF
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov