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Randomized Control Trial of Using Tongue Acupuncture in Autistic Spectrum Disorder Using PET Scan for Clinical Correlation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00355329
First Posted: July 21, 2006
Last Update Posted: October 20, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The University of Hong Kong
  Purpose
We aimed to use Tongue Acupuncture (TAC) to assess for any change in brain function.

Condition Intervention Phase
Autism Autistic Disorder Procedure: Tongue Acupuncture (Procedure) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Using Tongue Acupuncture in Autistic Spectrum Disorder Using PET Scan for Clinical Correlation

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

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

Estimated Enrollment: 30
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355329


Locations
Hong Kong
Duchess of Kent of Children Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Wong Virginia The University of Hong Kong
  More Information

ClinicalTrials.gov Identifier: NCT00355329     History of Changes
Other Study ID Numbers: PET-001
First Submitted: July 20, 2006
First Posted: July 21, 2006
Last Update Posted: October 20, 2006
Last Verified: July 1999

Keywords provided by The University of Hong Kong:
Traditional Chinese Medicine (TCM)
Autism
Autistic Spectrum Disorder
Tongue Acupuncture (TAC)
18F-fluorodeoxyglucose Positron Emission Tomography (PET)
children

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders


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