Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

Not Applicable

Withdrawn

• Conditions: Autism Spectrum Disorder
• Interventions: Drug: baclofen, intrathecal

• Registration Number: NCT01352611
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

The purpose of this study is to determine if intrathecal administration of baclofen can reduce symptoms of severe tactile defensiveness and autism spectrum disorder.

Detailed Description

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 Timeline

• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Study Start: 2014-09
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of autism prior to study entry

2. Exhibits these specific symptoms of autism:

   • Tactile Defensiveness
   • Increased sensitivity to sensory stimulation

3. Patients must be scored as "Always" for "Reacts emotionally or aggressively to touch" on a modified Short Sensory Profile Questionnaire. Additionally, patients must score "Always" or "Frequently" in the other categories of a modified Short Sensory Profile Questionnaire

Exclusion Criteria

1. Allergy to baclofen or compounds with similar structure
2. Unable to be evaluated by the chosen efficacy measures
3. Any condition that in the opinion of the principal investigator will place the patient at increased risk of adverse events or preclude completion of the study
4. Concomitant use of any medication that in the opinion of the principal investigator is contraindicated with intrathecal baclofen administration
5. Females of child-bearing potential who have a positive urine pregnancy test at visit 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
baclofen, intrathecal	baclofen, intrathecal	A single injection of 50 micrograms of baclofen between the 4th and 5th lumbar vertebrae into the spinal fluid.

Primary Outcome Measures

Name	Time	Method
Modified Short Sensory Profile.	Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen	Changes in tactile defensiveness will be documented on the tactile, movement, and visual/auditory sensitivity sub-scales of a Modified Short Sensory Profile.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of Change in Autism Symptoms	Baseline and 2, 4, and 6 hours after administration of intrathecal baclofen	Changes in symptoms of autism spectrum disorder from pre-treatment baseline to post-treatment.

Trial Locations

Locations (1)

University Hospital/University of Missouri Health Care; 🇺🇸 Columbia, Missouri, United States