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Completed

NCT Number: NCT00355329

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

We aimed to use Tongue Acupuncture (TAC) to assess for any change in brain function.

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Key information

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Duchess of Kent of Children Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tongue Acupuncture (Procedure)

Procedure

Primary outcomes

  1. Autism Treatment Evaluation Checklist (ATEC) consisting of 4 subscales before (Week 0) and after (Week 8) acupuncture

  2. Reynell Language Developmental Scale (RLDS) before (Week 0) and after (Week 8) acupuncture

  3. Symbolic Play Test (SPT) before (Week 0) and after (Week 8) acupuncture

  4. Functional Independence Measure for children (WeeFIM) with 3 domains before (Week 0) and after (Week 8) acupuncture

  5. Clinical Global Impression Scale (CGIS) before (Week 0) and after (Week 8) acupuncture

  6. 18F-fluorodeoxyglucose Positron Emission Tomography (PET) before (Week 0) and after (Week 8) acupuncture

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

First posted
Jul 21, 2006
Registry last updated
Oct 20, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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