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.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen|
- Modified Short Sensory Profile. [ Time Frame: Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen ] [ Designated as safety issue: No ]Changes in tactile defensiveness will be documented on the tactile, movement, and visual/auditory sensitivity sub-scales of a Modified Short Sensory Profile.
- Clinical Global Impression of Change in Autism Symptoms [ Time Frame: Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen ] [ Designated as safety issue: No ]Changes in symptoms of autism spectrum disorder from pre-treatment baseline to post-treatment.
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: baclofen, intrathecal
A single injection of 50 micrograms of baclofen between the 4th and 5th lumbar vertebrae into the spinal fluid.
Drug: baclofen, intrathecal
Patients will undergo a standard intrathecal baclofen trial procedure. This procedure consists of a single injection of 50 micrograms of baclofen between the 4th and 5th lumbar vertebrae into the spinal fluid.
Other Name: Lioresal, intrathecal.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352611
|United States, Missouri|
|University Hospital/University of Missouri Health Care|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Reza S. Farid, MD||University of Missouri-Columbia|