Use of Acupuncture In Children With Autistic Spectrum Disorder

Autism Clinical Trial

Official title:

Use of Acupuncture In Autistic Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346736
• Other study ID #: UW 04-096 T/418
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2006
• Last updated: September 1, 2008
• Start date: May 2005
• Est. completion date: March 2007

Study information

• Verified date: September 2008
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: HKSAR: Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• fulfilled the criteria for autism of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders on the basis of observation of the child, and

• fulfilled the criteria for autism of a structured diagnostic interview of a parent using Autism Diagnostic Interview-Revised, and

• had a score on the Childhood Autism Rating Scale of 30 or more, and

• Clinical Global Impression Scale of moderately ill or markedly ill or severely ill

Exclusion Criteria:

• children on chronic anti-epileptics or neuroleptics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Procedure:
• Acupuncture (Procedure)

Locations

Country	Name	City	State
Hong Kong	TWGHs Tung Wah Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aberrant Behavioral Checklist (ABC) will be completed by parents and teachers at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.
Primary	Ritvo-Freeman Real LIfe Scale (RFRLS) will be completed by parents and teachers at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.
Primary	Functional Independence Measure for Children (WeeFIM) will be conducted by trained Research Assistant at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.
Primary	Pediatric Evaluation Disability Inventory (PEDI) will be completed by parents and teachers at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.
Secondary	Leiter International Performance Scale-Revised will be conducted on patient by trained Research Assistant at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.
Secondary	Reynell Language Developmental Scale will be conducted on patient by trained Research Assistant at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.
Secondary	Symbolic Play Test will be conducted on patient by trained Research Assistant at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.
Secondary	Clinical Global Impression Scale (CGIS) will be self administered by parent and by trained Research Assistant at Week 0, once during Week 6 to Week 7, and once during Week 14 to Week 15.