Efficacy and Safety of Acupuncture in the Treatment of Tic Disorders in Children, Based on MR-DTI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 主要终点
- Yale Global Tic Severity Scal(YGTSS)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Acupuncture group
Behavioral intervention and acupuncture
干预措施: Acupuncture (Other)
Acupuncture group
Behavioral intervention and acupuncture
干预措施: Comprehensive Behavioral Intervention for Tics (CBIT) (Behavioral)
Waiting for acupuncture group
Behavioral intervention
干预措施: Comprehensive Behavioral Intervention for Tics (CBIT) (Behavioral)
Healthy control group
Healthy participants without intervention
结局指标
主要结局
Yale Global Tic Severity Scal(YGTSS)
时间窗: 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
时间窗: 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.
次要结局
- Pediatric quality of life inventory(baseline,4 weeks,8 weeks,6 months)
- Traditional Chinese Medicine Symptom Score(baseline,4 weeks,8 weeks,6 months)