Trial record 8 of 455 for:    "Autistic Disorder"

Use of Acupuncture In Children With Autistic Spectrum Disorder

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00352352
First received: July 13, 2006
Last updated: NA
Last verified: July 1999
History: No changes posted
  Purpose

This is a study of the efficacy of acupuncture in children with autism.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Using Acupuncture In Children With Autistic Spectrum Disorder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Ritvo-Freeman Real Life Scale (RFRLS) was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
  • Functional Independence Measure for children (WeeFIM) consists of 18 questions concerning on the Functional Independence Measure for children, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
  • Parental Stress Index (PSI) consists of child domain, parent domain and a total domain, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.
  • Clinical Global Impression Scale (CGIS) is a measure in a Likert scale of 0 – 7, which was conducted on both groups before (Week 0) and after (Week 8) acupuncture.

Estimated Enrollment: 30
Detailed Description:

Autism Spectrum Disorder (ASD) or autism is a neurodevelopmental disorder with unknown etiology. ASD consisted of 3 core features: 1) disorder of language or communication; 2) disorder of social interaction; and 3) obsessive and stereotypic behavior.

Acupuncture had been practiced in China for over two millennia. In Traditional Chinese Acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions. The approach in TCM, in sharp contrast to western medical concept, was a “holistic” approach with a philosophical background of balancing the “Yin-and-Yang”. The main objective of TCM was to improve health of body and mind by deblocking the flow of “Qi” in the body. The pathophysiological basis of TCM aimed to improve “energy” or “body-flow” or “Qi” [“de-qui” in Chinese]. The effect of acupuncture was had been proven in animal and human studies to be due to direct neural stimulation, changes in neurotransmitters such as endorphin, immunological markers or endocrinological signals. Thus, acupuncture is especially effective in chronic disorders, especially neurological ones.

As there is no TCM concept of mental retardation or autism, we propose that ASD is part of the spectrum of the TCM concept of the “Four Delayed Syndrome” in children with “delay in motor skills, speech, hair and teeth eruption” according to TCM concept. Thus, we approach ASD according to TCM concept as part of the lower intelligence due to imbalance of “Heart meridian and Kidney meridian” (i.e. yin-yang imbalance) resulting in communication problem and “Liver meridian” (yin-yang imbalance) leading to behavioral problems.

Our objective is to use a different approach in looking at ASD and to assess the efficacy of TCM model in improving the functional status of these children. Specific acupoints corresponding to various organs and meridians were used for ASD. The organ and meridian concept in TCM model has been as a fundamental basis to improve the behavior, cognition and communicative ability in children with ASD.

  Eligibility

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The diagnosis of ASD or autism was made according to the 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 it satisfied a score greater than 30 in the Childhood Autism Rating Scale (CARS).

Exclusion Criteria:

  • Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352352

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

No publications provided

ClinicalTrials.gov Identifier: NCT00352352     History of Changes
Other Study ID Numbers: 3469296479554546
Study First Received: July 13, 2006
Last Updated: July 13, 2006
Health Authority: HKSAR: Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster

Keywords provided by The University of Hong Kong:
Traditional Chinese Medicine (TCM)
Alternative Medicine (AM)
Tongue Acupuncture (TAC)
Autism Spectrum Disorder (ASD)
Autism
Children

Additional relevant MeSH terms:
Disease
Autistic Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014