NCT00355329

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2006

Completed
Last Updated

October 20, 2006

Status Verified

July 1, 1999

First QC Date

July 20, 2006

Last Update Submit

October 19, 2006

Conditions

AutismAutistic Disorder

Keywords

Traditional Chinese Medicine (TCM)AutismAutistic Spectrum DisorderTongue Acupuncture (TAC)18F-fluorodeoxyglucose Positron Emission Tomography (PET)children

Outcome Measures

Primary Outcomes (6)

  • 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

Interventions

Tongue Acupuncture (Procedure)PROCEDURE

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duchess of Kent of Children Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Wong Virginia

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2006

First Posted

July 21, 2006

Last Updated

October 20, 2006

Record last verified: 1999-07

Locations

HK(1)