Efficacy and Safety of Acupuncture in the Treatment of Tic Disorders in Children, Based on MR-DTI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 102
- Primary Endpoint
- Yale Global Tic Severity Scal(YGTSS)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Acupuncture group
Behavioral intervention and acupuncture
Intervention: Acupuncture (Other)
Acupuncture group
Behavioral intervention and acupuncture
Intervention: Comprehensive Behavioral Intervention for Tics (CBIT) (Behavioral)
Waiting for acupuncture group
Behavioral intervention
Intervention: Comprehensive Behavioral Intervention for Tics (CBIT) (Behavioral)
Healthy control group
Healthy participants without intervention
Outcomes
Primary Outcomes
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.
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
- Pediatric quality of life inventory(baseline,4 weeks,8 weeks,6 months)
- Traditional Chinese Medicine Symptom Score(baseline,4 weeks,8 weeks,6 months)