Randomized Control Trial of Using Tongue Acupuncture in Autistic Spectrum Disorder Using PET Scan for Clinical Correlation
Primary Purpose
Autism, Autistic Disorder
Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Tongue Acupuncture (Procedure)
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Traditional Chinese Medicine (TCM), Autism, Autistic Spectrum Disorder, Tongue Acupuncture (TAC), 18F-fluorodeoxyglucose Positron Emission Tomography (PET), children
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
Sites / Locations
- Duchess of Kent of Children Hospital
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00355329
First Posted
July 20, 2006
Last Updated
October 19, 2006
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00355329
Brief Title
Randomized Control Trial of Using Tongue Acupuncture in Autistic Spectrum Disorder Using PET Scan for Clinical Correlation
Official Title
Randomized Control Trial of Using Tongue Acupuncture in Autistic Spectrum Disorder Using PET Scan for Clinical Correlation
Study Type
Interventional
2. Study Status
Record Verification Date
July 1999
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
The University of Hong Kong
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autistic Disorder
Keywords
Traditional Chinese Medicine (TCM), Autism, Autistic Spectrum Disorder, Tongue Acupuncture (TAC), 18F-fluorodeoxyglucose Positron Emission Tomography (PET), children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Tongue Acupuncture (Procedure)
Primary Outcome Measure Information:
Title
Autism Treatment Evaluation Checklist (ATEC) consisting of 4 subscales before (Week 0) and after (Week 8) acupuncture
Title
Reynell Language Developmental Scale (RLDS) before (Week 0) and after (Week 8) acupuncture
Title
Symbolic Play Test (SPT) before (Week 0) and after (Week 8) acupuncture
Title
Functional Independence Measure for children (WeeFIM) with 3 domains before (Week 0) and after (Week 8) acupuncture
Title
Clinical Global Impression Scale (CGIS) before (Week 0) and after (Week 8) acupuncture
Title
18F-fluorodeoxyglucose Positron Emission Tomography (PET) before (Week 0) and after (Week 8) acupuncture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wong Virginia
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duchess of Kent of Children Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
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Randomized Control Trial of Using Tongue Acupuncture in Autistic Spectrum Disorder Using PET Scan for Clinical Correlation
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