Acupuncture Treament in Children With Tic Disorders

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorMeizhou People's Hospital

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Other intervention

    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

Treatment groups

102 Participants
are divided into 3 treatment groups
Group A: Acupuncture groupExperimental treatment 2 interventions
Group B: Waiting for acupuncture groupOther 1 intervention
Group C: Healthy control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Yale Global Tic Severity Scal(YGTSS)

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.

Time frame
baseline,4 weeks,8 weeks,6 months
2

MR-DTI

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.

Time frame
baseline,8 weeks

Secondary outcomes

1

Pediatric quality of life inventory

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.

Time frame
baseline,4 weeks,8 weeks,6 months
2

Traditional Chinese Medicine Symptom Score

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.

Time frame
baseline,4 weeks,8 weeks,6 months

Other outcomes

1

Acupuncture-Related Adverse Events

All adverse events occurring during the intervention will be recorded

Time frame
8 weeks

Locations

This trial has no locations.

Sponsors and contacts

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