Tic Disorder, Childhood
Conditions
Keywords
Tic disorers, Acupuncture, Magnetic Resonance Diffusion Tensor Imaging
Brief summary
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).
Interventions
OTHERAcupuncture
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) 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
Sponsors
Meizhou People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale Global Tic Severity Scal(YGTSS) | 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. |
| MR-DTI | 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
| Measure | Time frame | Description |
|---|---|---|
| Pediatric quality of life inventory | 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. |
| Traditional Chinese Medicine Symptom Score | 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. |
Contacts
CONTACTZhongtao Song, PhD
Outcome results
None listed