Clinical trial NCT00355329: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autism
Autistic Disorder
Keywords: Traditional Chinese Medicine (TCM)
Autism
Autistic Spectrum Disorder
Tongue Acupuncture (TAC)
18F-fluorodeoxyglucose Positron Emission Tomography (PET)
children
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2006-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Autism Treatment Evaluation Checklist (ATEC) consisting of 4 subscales before (Week 0) and after (Week 8) acupuncture
measure: Reynell Language Developmental Scale (RLDS) before (Week 0) and after (Week 8) acupuncture
measure: Symbolic Play Test (SPT) before (Week 0) and after (Week 8) acupuncture
measure: Functional Independence Measure for children (WeeFIM) with 3 domains before (Week 0) and after (Week 8) acupuncture
measure: Clinical Global Impression Scale (CGIS) before (Week 0) and after (Week 8) acupuncture
measure: 18F-fluorodeoxyglucose Positron Emission Tomography (PET) before (Week 0) and after (Week 8) acupuncture
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Duchess of Kent of Children Hospital
Study officials:
affiliation: The University of Hong Kong
name: Wong Virginia
role: PRINCIPAL_INVESTIGATOR
References: