Tic Disorder, ChildhoodNCT07588815
Acupuncture Treament in Children With Tic Disorders
A study testing Acupuncture and Comprehensive Behavioral Intervention for Tics (CBIT) in people with Tic Disorder, Childhood, run by Meizhou People's Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tic Disorder, Childhood
- What is being tested?
- Acupuncture and Comprehensive Behavioral Intervention for Tics (CBIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Acupuncture in the Treatment of Tic Disorders in Children, Based on MR-DTI
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).
- Conditions
- Tic Disorder, Childhood
- Being tested
- Acupuncture, Comprehensive Behavioral Intervention for Tics (CBIT)
- Keywords
- Tic disorers, Acupuncture, Magnetic Resonance Diffusion Tensor Imaging
- Medical subject headings
- Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Behavioral intervention and acupuncture Receives: Other: Acupuncture; Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT) |
| Waiting for acupuncture group | Other | Behavioral intervention Receives: Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT) |
| Healthy control group | No intervention | Healthy participants without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline,8 weeks
Secondary outcomes (2)
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.
Measured: baseline,4 weeks,8 weeks,6 months
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.
Measured: baseline,4 weeks,8 weeks,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startJun 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tic Disorder, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meizhou People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588815
- Sponsor's protocol ID
- MZPH202604001
- Status last verified
- May 2026
- First submitted
- 29 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acupuncture in the Treatment of Tic Disorders in Children, Based on MR-DTI
- ClinicalTrials.gov ID
- NCT07588815
- Acronym / sponsor ID
- MZPH202604001
- Conditions
- Tic Disorder, Childhood
- Keywords
- Tic disorers, Acupuncture, Magnetic Resonance Diffusion Tensor Imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Meizhou People's HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: Acupuncture, Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)Behavioral intervention and acupuncture |
| Waiting for acupuncture group | Other | Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)Behavioral intervention |
| Healthy control group | No intervention | –Healthy participants without intervention |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe 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). | Other | Acupuncture group |
| Comprehensive Behavioral Intervention for Tics (CBIT)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 | Behavioural | Acupuncture group, Waiting for acupuncture group |
Primary outcome
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.
2 secondary outcomes
Pediatric quality of life inventory
Time frame: baseline,4 weeks,8 weeks,6 months
Traditional Chinese Medicine Symptom Score
Time frame: baseline,4 weeks,8 weeks,6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Comprehensive Behavioral Intervention for Tics (CBIT) in people with Tic Disorder, Childhood, run by Meizhou People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongtao Song, PhD (0086-19820151649, songzhongtao1@mzrmyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Global Tic Severity Scal(YGTSS) (time frame: baseline,4 weeks,8 weeks,6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.