Acupuncture Treament in Children With Tic Disorders

May 8, 2026 updated by: Meizhou People's Hospital

Efficacy and Safety of Acupuncture in the Treatment of Tic Disorders in Children, Based on MR-DTI

This study intends to evaluate the efficacy of acupuncture on tic disorders in Children; and to explore the underlying mechanism of acupuncture intervention on tic disorders based on Magnetic Resonance Diffusion Tensor Imaging(MR-DTI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Must meet the diagnostic criteria for Provisional Tic Disorder (PTD) or Persistent (Chronic) Motor or Vocal Tic Disorder (CTD)
  • Right-handed children aged 5-18 years
  • Have not previously received systematic acupuncture treatment and are able to adhere to acupuncture treatment for ≥ 2 months
  • Complete medical records available
  • Not currently participating in any other clinical study
  • Voluntary participants, with the signature and consent of their guardians, and children aged 8 and above obtaining their own informed consent

Exclusion Criteria:

  • History of hepatolenticular degeneration (Wilson's disease), rheumatic chorea, childhood migraine, epilepsy, intellectual disability, schizophrenia, or other related conditions
  • Presence of organic neurological diseases or other severe conditions significantly impacting quality of life
  • Recent use of centrally-acting medications
  • Inability to regularly complete the acupuncture treatment regimen
  • Inability to undergo the MR-DTI examination
  • Refusal to sign the written informed consent form
  • Inability of the child or guardian to cooperate during the treatment and follow-up process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acupuncture group
Behavioral intervention and acupuncture
Other: Acupuncture
The Acupuncture point prescription is as follows: Sishencong (EX-HN1), bilateral Shuaigu (GB8), bilateral Yangbai (GB14), bilateral Sibai (ST2), bilateral Fengchi (GB20), bilateral Fenglong (ST40), bilateral Hegu (LI4), and bilateral Taichong (LR3). Points will be selected based on Traditional Chinese Medicine syndrome differentiation, with location standardized according to the 2006 National Standard of the People's Republic of China (GB/T 12346-2006), "Nomenclature and Location of Acupuncture Points." After routine skin disinfection, Sishencong will be obliquely needled to a depth of 0.5 cun, and the remaining points will be perpendicularly needled to a depth of 1 cun. The twirling manipulation will be applied until the needling sensation (Deqi) is locally achieved. Needles will be retained for 30 minutes. Treatment will be administered once daily, 5 times per week, for a total of 8 weeks (40 sessions).
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
Comprehensive Behavioral Intervention for Tics (CBIT) is recommended as a first-line intervention by organizations such as the American Academy of Neurology.It consists of several core components: Psychoeducation,Awareness Training,Competing Response Training,Function-Based Intervention and Social Support and Relapse Prevention
Other: Waiting for acupuncture group
Behavioral intervention
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
Comprehensive Behavioral Intervention for Tics (CBIT) is recommended as a first-line intervention by organizations such as the American Academy of Neurology.It consists of several core components: Psychoeducation,Awareness Training,Competing Response Training,Function-Based Intervention and Social Support and Relapse Prevention
No Intervention: Healthy control group
Healthy participants without intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Yale Global Tic Severity Scal(YGTSS)
Time Frame: baseline,4 weeks,8 weeks,6 months
The Yale Global Tic Severity Scale (YGTSS) Score is designed to assess the severity of symptoms in children with TD by scoring the type of tics, frequency of tics, intensity of tics, complexity of tics, degree of interference with normal behavior, and degree of impairment of social functioning in the child, with a total score ranging from 0-75, with higher scores indicating greater severity of the child's condition.
baseline,4 weeks,8 weeks,6 months
MR-DTI
Time Frame: baseline,8 weeks
Magnetic Resonance Diffusion Tensor Imaging(MR-DTI).Scanning will employ a single-shot echo-planar imaging sequence with 15 diffusion gradient directions. Software such as DTI Studio will be used to calculate the Mean Diffusivity (MD), Fractional Anisotropy (FA), and Apparent Diffusion Coefficient (ADC) values for each subject's corpus callosum, bilateral globus pallidus, thalamus, putamen, and caudate nucleus.
baseline,8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pediatric quality of life inventory
Time Frame: baseline,4 weeks,8 weeks,6 months
Pediatric quality of life inventory 4.0(PedsQL 4.0) is composed of 23 items comprising 4 dimensions: : 1) Physical Functioning (8 items), 2) Emotional Functioning (5 items), 3) Social Functioning (5 items), and 4) School Functioning (5 items). Higher scores indicate better HRQOL with a range of 0-100.
baseline,4 weeks,8 weeks,6 months
Traditional Chinese Medicine Symptom Score
Time Frame: baseline,4 weeks,8 weeks,6 months
Traditional Chinese medicine symptom score is used to assess overall health status, including aspects such as mood, appearance, sleep, diet, and gastrointestinal function. Higher scores indicate more severe symptoms with a range of 0-100.
baseline,4 weeks,8 weeks,6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acupuncture-Related Adverse Events
Time Frame: 8 weeks
All adverse events occurring during the intervention will be recorded
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meizhou People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MZPH202604001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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