Use of Acupuncture In Children With Autistic Spectrum Disorder
Condition: Autistic Disorder; Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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)

        -  Subject Recruitment Parents will be informed with regard to the nature of the study,
           potential risks and benefits. Consent forms for enrolment, photographs/Videos taking
           will be obtained.

        -  A semi-structured diagnostic interview with the parents and neurological examination
           will be conducted.

        -  Assessment of outcomes will be performed by trained research assistant, being blinded to
           the treatment or control group.

      Methodology:

      R will consist of a total course of 12 sessions, with 3 sessions per week for 4 weeks.

        -  Acupuncture (AC) will be applied to specific body and scalp acupoints using sterile
           disposable 0.3 x 4-cm acupuncture needle (Made in China -HwaTo).

        -  EA instrument (Model SDZ-II Electronic Acupuncture Treatment Instrument, Suzhou China)
           will be connected to the handles of acupuncture needles to provide electrical
           stimulation for 25 minutes. No sedation is required.

      S will consist of a total course of 12 sessions, with 3 sessions per week for 4 weeks.

      * AC will insert into points that 5 to 10 mm away from the correct acupoint locations and
      maintained at a superficial level of insertion to minimize stimulation, and with the same EA.

      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):

      * Treatment AC for 4 weeks (3 times per week), then wash out for 2 weeks; then Sham
      acupuncture 3 times per week for 4 weeks

      Control Arm:

      * Sham acupuncture for 4 weeks (3 times per week), then wash out for 2 weeks; then Real
      acupuncture 3 times per week for 4 weeks

      Assessment tools:

        -  Children will be assessed before (Week 0), washout period (Week 6) and after Treatment
           (Week 14).

        -  Control group will undergo same assessment and reassessment procedures during the same
           period.
    

Intervention name(s): Acupuncture (Procedure)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alternative medicine; Traditional Chinese medicine; Acupuncture; Autistic Spectrum Disorder; Autism; Children