Autism Spectrum Disorder Clinical Trial
Official title:
Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen
The purpose of this study is to determine if intrathecal administration of baclofen can reduce symptoms of severe tactile defensiveness and autism spectrum disorder.
The purpose of this study is to determine if intrathecal administration of baclofen can
reduce symptoms of severe tactile defensiveness and autism spectrum disorder.
Some people with autism spectrum disorder do not like to be touched. This is referred to as
tactile defensiveness. Baclofen is a drug approved for treatment of spasticity in patients
with conditions such as cerebral palsy, spinal cord injury and traumatic brain injury.
Intrathecal means that baclofen is administered by injection into the spinal canal. In this
study, each patient will undergo a trial administration of intrathecal baclofen and the
effect of intrathecal baclofen on symptoms of tactile defensiveness and autism spectrum
disorder will be evaluated.
Each patient will have three visits in connection with the study. First, there will be a
screening visit in which the investigators determine if the patient is eligible to
participate in the study. To participate, each patient must have autism spectrum disorder,
severe tactile defensiveness, and meet other listed criteria. At the second visit, each
patient will undergo the intrathecal baclofen trial procedure. The procedure used is the
standard procedure to determine if intrathecal baclofen is effective for treatment of
spasticity. In this study however, instead of evaluating the effect of intrathecal baclofen
on spasticity, the investigators will evaluate the effect of intrathecal baclofen on
symptoms of tactile defensiveness and autism spectrum disorder. The trial procedure and
evaluation will require about one day. At the third visit, the follow up visit, the
investigators will evaluate and discuss the patient's response to the treatment.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05207956 -
App for Strengthening Services In Specialized Therapeutic Support
|
N/A | |
Completed |
NCT03286621 -
Development of Eye-tracking Based Markers for Autism in Young Children
|
||
Completed |
NCT02608333 -
Efficiency of Early Intervention for Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
Active, not recruiting |
NCT06303791 -
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
|
N/A | |
Enrolling by invitation |
NCT05017779 -
A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth
|
N/A | |
Completed |
NCT04772898 -
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT04987541 -
The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder
|
N/A | |
Completed |
NCT04308915 -
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
|
N/A | |
Completed |
NCT06038435 -
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
|
N/A | |
Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
Completed |
NCT03693313 -
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
|
N/A | |
Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
Recruiting |
NCT03812068 -
Parent-mediated Developmental Behavioral Intervention
|
N/A | |
Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
Completed |
NCT02299700 -
Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
|
N/A | |
Completed |
NCT03422016 -
Electroretinogram in Autistic Spectrum Disorders
|
||
Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
Recruiting |
NCT05114538 -
Improving the Part C Early Intervention Service Delivery System for Children With ASD
|
N/A |