Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529380
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-26
Brief Title:
Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Deep Brain Stimulation for the Treatment of Severe Refractory Self-Injurious Behaviour in Children with Autism Spectrum Disorder a Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
The proposed study is a single-center double-blinded block-randomized crossover trial
Twenty 20 participants will be recruited and enrolled in this trial to undergo bilateral nucleus accumbens DBS After recovery participants will be randomized to a 3 month block of active stimulation or the DBS will remain off After a two week washout period the participants will cross over to the other group At the end of the second block all patients will have their DBS devices activated during an open label period All participants will have baseline assessments that will be repeated at the end of each block
Expected study duration is 24 months
Twenty 20 participants will be recruited and enrolled in this trial to undergo bilateral nucleus accumbens DBS After recovery participants will be randomized to a 3 month block of active stimulation or the DBS will remain off After a two week washout period the participants will cross over to the other group At the end of the second block all patients will have their DBS devices activated during an open label period All participants will have baseline assessments that will be repeated at the end of each block
Expected study duration is 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None