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NCT Number: NCT07588815

Acupuncture Treament in Children With Tic Disorders

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).

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Key information

Conditions

Tic Disorder, Childhood Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodevelopmental Disorders Tic Disorders

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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).

Comprehensive Behavioral Intervention for Tics (CBIT)

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Acupuncture-Related Adverse Events

    Time frame: 8 weeks

    All adverse events occurring during the intervention will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongtao Song, PhD

CONTACT

[email protected]

0086-19820151649

Sponsors and collaborators

Lead sponsor

Meizhou People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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