NCT07588815

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).

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
48mo left

Started Jun 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

April 29, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

Tic disorersAcupunctureMagnetic Resonance Diffusion Tensor Imaging

Outcome Measures

Primary Outcomes (2)

  • 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.

    baseline,4 weeks,8 weeks,6 months

  • 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.

    baseline,8 weeks

Secondary Outcomes (2)

  • Pediatric quality of life inventory

    baseline,4 weeks,8 weeks,6 months

  • Traditional Chinese Medicine Symptom Score

    baseline,4 weeks,8 weeks,6 months

Other Outcomes (1)

  • Acupuncture-Related Adverse Events

    8 weeks

Study Arms (3)

Acupuncture group

EXPERIMENTAL

Behavioral intervention and acupuncture

Other: AcupunctureBehavioral: Comprehensive Behavioral Intervention for Tics (CBIT)

Waiting for acupuncture group

OTHER

Behavioral intervention

Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)

Healthy control group

NO INTERVENTION

Healthy participants without intervention

Interventions

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).

Acupuncture group

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

Acupuncture groupWaiting for acupuncture group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tic Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 15, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2030

Last Updated

May 15, 2026

Record last verified: 2026-05