AutismPhase 3NCT00355329
Randomized Control Trial of Using Tongue Acupuncture in Autistic Spectrum Disorder Using PET Scan for Clinical Correlation
A Phase 3 study testing Tongue Acupuncture (Procedure) in people with Autism and Autistic Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
We aimed to use Tongue Acupuncture (TAC) to assess for any change in brain function. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Autism, Autistic Disorder
- What is being tested?
- Tongue Acupuncture (Procedure)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- Start not givento not given
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The diagnosis of autism was made using standard criteria of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Autism Diagnostic Interview-Revised (ADI-R).
- The diagnosis of autism was made if the score in the Childhood Autism Rating Scale (CARS)was greater than 30.
Who cannot join
- Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
We aimed to use Tongue Acupuncture (TAC) to assess for any change in brain function.
Read the detailed description
Autism or Autistic Spectrum Disorder is a neurodevelopmental disorder affecting language, communication, social interaction and behavior. Autism is a heterogeneous disorder makes the assessment of treatment difficult. Only few measures have been used in a standardized way to document the outcome of different modalities of treatment in autism. Most claims of treatment effect in autism have been quite anecdotal.
In Traditional Chinese acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions. Acupuncture had been practiced in China for over 2 millennia. The surface acupoints are linked through 14 meridians to various organs or viscera of the human body. The approach in TCM, in sharp contrast to western medical concept, is a "holistic" approach with a more philosophical background of balancing the "Yin-and-Yang". The main objective of TCM is to improve health of body and mind.
The pathophysiological basis of TCM aimed to improve "energy" or "body-flow" ["de-qui" in Chinese]. Even a normal human subject will respond to acupuncture due to the flow of energy. The effect of acupuncture was hypothesized and proven in animal and human studies to be due to direct neural stimulation, changes in neurotransmitters such as endorphin, immunological markers and endocrinological signals. Thus, acupuncture is Thus, acupuncture is effective in chronic disorders, especially in neurological disorders.
We had demonstrated clinical efficacy of acupuncturing the surface or base of the tongue in specific acupoints in improving various functional modalities in patients with chronic neurological disorders such as cerebral palsy, stroke and drooling problems. In our experience, TCM approach for autism is more holistic. Autism is postulated as part of the spectrum of lower intelligence. Thus, the approach to autism is considered as lower intelligence due to "Heart-meridian and Kidney-meridian yin-yang imbalance" resulting in communication problem and "Liver-meridian yin-yang imbalance " leading to behavioral problems.
We attempted to use a different approach in looking at autism and to assess the efficacy of an innovative method in TCM in improving the functional status of these children. Specific acupoints in the tongue corresponding to various organs and meridians were used for autism. The organ and meridian concept in TCM model has been assumed as a fundamental basis to improve the behavior, cognition and communicative ability in children with autism. The objective is to study the efficacy of a short course of TAC in improving the overall functional status of autism.
- Conditions
- Autism, Autistic Disorder
- Being tested
- Tongue Acupuncture (Procedure)
- Keywords
- Traditional Chinese Medicine (TCM), Autism, Autistic Spectrum Disorder, Tongue Acupuncture (TAC), 18F-fluorodeoxyglucose Positron Emission Tomography (PET), 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.
Tongue Acupuncture (Procedure)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Treatment Evaluation Checklist (ATEC) consisting of 4 subscales before (Week 0) and after (Week 8) acupuncture
Reynell Language Developmental Scale (RLDS) before (Week 0) and after (Week 8) acupuncture
Symbolic Play Test (SPT) before (Week 0) and after (Week 8) acupuncture
Functional Independence Measure for children (WeeFIM) with 3 domains before (Week 0) and after (Week 8) acupuncture
Clinical Global Impression Scale (CGIS) before (Week 0) and after (Week 8) acupuncture
18F-fluorodeoxyglucose Positron Emission Tomography (PET) before (Week 0) and after (Week 8) acupuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
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
- NCT00355329
- Sponsor's protocol ID
- PET-001
- Status last verified
- Jul 1999
- First submitted
- 20 Jul 2006
- Last updated
- 20 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Using Tongue Acupuncture in Autistic Spectrum Disorder Using PET Scan for Clinical Correlation
- ClinicalTrials.gov ID
- NCT00355329
- Acronym / sponsor ID
- PET-001
- Conditions
- Autism, Autistic Disorder
- Keywords
- Traditional Chinese Medicine (TCM), Autism, Autistic Spectrum Disorder, Tongue Acupuncture (TAC), 18F-fluorodeoxyglucose Positron Emission Tomography (PET), children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- First posted
- 21 Jul 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.
We aimed to use Tongue Acupuncture (TAC) to assess for any change in brain function.
Detailed description
Autism or Autistic Spectrum Disorder is a neurodevelopmental disorder affecting language, communication, social interaction and behavior. Autism is a heterogeneous disorder makes the assessment of treatment difficult. Only few measures have been used in a standardized way to document the outcome of different modalities of treatment in autism. Most claims of treatment effect in autism have been quite anecdotal.
In Traditional Chinese acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions. Acupuncture had been practiced in China for over 2 millennia. The surface acupoints are linked through 14 meridians to various organs or viscera of the human body. The approach in TCM, in sharp contrast to western medical concept, is a "holistic" approach with a more philosophical background of balancing the "Yin-and-Yang". The main objective of TCM is to improve health of body and mind.
The pathophysiological basis of TCM aimed to improve "energy" or "body-flow" ["de-qui" in Chinese]. Even a normal human subject will respond to acupuncture due to the flow of energy. The effect of acupuncture was hypothesized and proven in animal and human studies to be due to direct neural stimulation, changes in neurotransmitters such as endorphin, immunological markers and endocrinological signals. Thus, acupuncture is Thus, acupuncture is effective in chronic disorders, especially in neurological disorders.
We had demonstrated clinical efficacy of acupuncturing the surface or base of the tongue in specific acupoints in improving various functional modalities in patients with chronic neurological disorders such as cerebral palsy, stroke and drooling problems. In our experience, TCM approach for autism is more holistic. Autism is postulated as part of the spectrum of lower intelligence. Thus, the approach to autism is considered as lower intelligence due to "Heart-meridian and Kidney-meridian yin-yang imbalance" resulting in communication problem and "Liver-meridian yin-yang imbalance " leading to behavioral problems.
We attempted to use a different approach in looking at autism and to assess the efficacy of an innovative method in TCM in improving the functional status of these children. Specific acupoints in the tongue corresponding to various organs and meridians were used for autism. The organ and meridian concept in TCM model has been assumed as a fundamental basis to improve the behavior, cognition and communicative ability in children with autism. The objective is to study the efficacy of a short course of TAC in improving the overall functional status of autism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The diagnosis of autism was made using standard criteria of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Autism Diagnostic Interview-Revised (ADI-R).
- The diagnosis of autism was made if the score in the Childhood Autism Rating Scale (CARS)was greater than 30.
Key exclusion criteria (1 listed)
- Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
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 |
|---|---|---|
| Tongue Acupuncture (Procedure) | Procedure or surgery | – |
Primary outcome
Autism Treatment Evaluation Checklist (ATEC) consisting of 4 subscales before (Week 0) and after (Week 8) acupuncture
Reynell Language Developmental Scale (RLDS) before (Week 0) and after (Week 8) acupuncture
Symbolic Play Test (SPT) before (Week 0) and after (Week 8) acupuncture
Functional Independence Measure for children (WeeFIM) with 3 domains before (Week 0) and after (Week 8) acupuncture
Clinical Global Impression Scale (CGIS) before (Week 0) and after (Week 8) acupuncture
18F-fluorodeoxyglucose Positron Emission Tomography (PET) before (Week 0) and after (Week 8) acupuncture
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 20 Oct 2006.
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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 Tongue Acupuncture (Procedure) in people with Autism and Autistic Disorder, 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 2 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 20 Oct 2006. 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?
Autism Treatment Evaluation Checklist (ATEC) consisting of 4 subscales before (Week 0) and after (Week 8) acupuncture. The study lists 6 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 20 Oct 2006.