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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Autistic Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Traditional Chinese Medicine (TCM) Autism Autistic Spectrum Disorder Tongue Acupuncture (TAC) 18F-fluorodeoxyglucose Positron Emission Tomography (PET) children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tongue Acupuncture (Procedure)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wong Virginia

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duchess of Kent of Children Hospital

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PET-001

Identifier Type: -

Identifier Source: org_study_id