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Sponsored by: |
The University of Hong Kong |
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Information provided by: | The University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00346736 |
Autism is a behaviorally defined, lifelong disorder of the brain, affecting at least 1-2 per 1000 children. There is an increasing trend of autism worldwide. However, to date, there is still no cure for this devastating childhood disease. Autism is characterized by deficit in language, social communication and repetitive behavior. It is estimated that the annual cost of care for autism is $13 billion in USA alone. Children with autism usually have associated behavioral problems such as aggressiveness, stereotypes, hyperactivity, emotional lability, and short attention span.
The National Institute of Child Health & Human Development and National Institute of Deafness & Communication Disorders have jointly founded the Collaborative Programs of Excellence in Autism. One of the long-term NIH goals is to develop or refine interim treatment strategy and to develop effective biological, behavioral or alternative treatment strategy for autism. There is a dire need for early identification and treatment of children with autism.
Acupuncture has been practised in China for 2 millennia. The legal status of acupuncture as a treatment technique was approved by Food & Drugs Administration in USA (1997). The therapeutic effect of acupuncture is based on stimulation at specific acupoints resulting in both local and distant effect via improving signal or modulation of electromagnetic energy. There had lack of studies of acupuncture in autism. We hope that we can study the efficacy of acupuncture in autism using clinical measurement. We hope to identify the role of acupuncture as an adjunctive treatment for autism.
Condition | Intervention | Phase |
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Autistic Disorder Autism |
Procedure: Acupuncture (Procedure) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Use of Acupuncture In Autistic Spectrum Disorder |
Estimated Enrollment: | 80 |
Study Start Date: | May 2005 |
Study Completion Date: | March 2007 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
The aim of this study is to assess whether alternative treatment strategy such as traditional Chinese acupuncture can improve the following parameters in children with Autism (or Autistic Spectrum Disorder): cognition, communication, function and behaviour.
Randomized double-blind controlled cross-over trial in Autism: Real electro-acupuncture (R) versus Sham electroacupuncture (S)
Methodology:
R will consist of a total course of 12 sessions, with 3 sessions per week for 4 weeks.
S will consist of a total course of 12 sessions, with 3 sessions per week for 4 weeks.
For both R and S, electrical stimulation was monitored by an indicator light throughout the treatment period. To ensure the integrity of blinding, the acupuncturist will not discuss the acupuncture procedure with the parents or patients.
Treatment Arm (AC):
Control Arm:
Assessment tools:
Ages Eligible for Study: | 3 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | UW 04-096 T/418 |
Study First Received: | June 29, 2006 |
Last Updated: | September 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00346736 History of Changes |
Health Authority: | HKSAR: Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster |
Alternative medicine Traditional Chinese medicine Acupuncture |
Autistic Spectrum Disorder Autism Children |
Child Development Disorders, Pervasive Developmental Disabilities Mental Disorders |
Autistic Disorder Mental Disorders Diagnosed in Childhood Autism |
Child Development Disorders, Pervasive Pathologic Processes Disease |
Mental Disorders Autistic Disorder Mental Disorders Diagnosed in Childhood |