Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346736
Status:
COMPLETED
Last Update Posted:
2008-09-03
First Post:
2006-06-29
Brief Title:
Use of Acupuncture In Children With Autistic Spectrum Disorder
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Use of Acupuncture In Autistic Spectrum Disorder
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 photographsVideos 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 03 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
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 photographsVideos 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 03 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None