Autistic DisorderPhase 3NCT00346736
Use of Acupuncture In Children With Autistic Spectrum Disorder
A Phase 3 study testing Acupuncture (Procedure) in people with Autistic Disorder and Autism, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Autistic Disorder, Autism
- What is being tested?
- Acupuncture (Procedure)
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2005to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- children on chronic anti-epileptics or neuroleptics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Acupuncture In Autistic Spectrum Disorder
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.
Read the 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.
- Conditions
- Autistic Disorder, Autism
- Being tested
- Acupuncture (Procedure)
- Keywords
- Alternative medicine, Traditional Chinese medicine, Acupuncture, Autistic Spectrum Disorder, Autism, Children
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture (Procedure)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
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 outcomes (4)
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.
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.
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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startMay 2005
- Primary completionJun 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Wong Virginia, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346736
- Sponsor's protocol ID
- UW 04-096 T/418
- Status last verified
- Sep 2008
- First submitted
- 29 Jun 2006
- Last updated
- 3 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Acupuncture In Autistic Spectrum Disorder
- ClinicalTrials.gov ID
- NCT00346736
- Acronym / sponsor ID
- UW 04-096 T/418
- Conditions
- Autistic Disorder, Autism
- Keywords
- Alternative medicine, Traditional Chinese medicine, Acupuncture, Autistic Spectrum Disorder, Autism, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 30 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- children on chronic anti-epileptics or neuroleptics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture (Procedure) | Procedure or surgery | – |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wong Virginia principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupuncture (Procedure) in people with Autistic Disorder and Autism, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2008.