Clinical trial NCT06924918: Scalp Acupuncture Treatment for Chronic Tic Disorders in Children
Official title: Scalp Acupuncture Treatment for Chronic Tic Disorders in Children: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tic Disorder
Keywords: Tic Disorder
scalp acupuncture treatment
Multicenter Randomized Controlled Trial
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 136
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an outcome assessor and data analyst-blinded, randomized, controlled superiority trial.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if scalp acupuncture works to treat chronic tic disorders (CTD) in children. It will also learn about the safety of scalp acupuncture. The main questions it aims to answer are:

* Does scalp acupuncture improve clinical symptoms and social functioning, and enhance quality of life in children with chronic tic disorders?
* Researchers will compare scalp acupuncture combined with behavioral therapy to behavioral therapy to see if scalp acupuncture treatment works to treat scalp acupuncture.

Participants will:

* Receive scalp acupuncture treatment and behavioral therapy for 3 times per week and last for 12 weeks.
* Receive questionnaire survey using the following scales: the Yale Global Tic Severity Scale (YGTSS), the Clinical Global Impression (CGI) Scale, the Children and Adolescents Quality of Life Scale for Tourette Syndrome (C\&A-GTS-QOL) and the Child Behavior Checklist (CBCL).

Detailed description: Tourette Disorder (TD), which includes Temporary Tic Disorder (TTD), Chronic Motor or Vocal Tic Disorder (CTD), and Tourette Syndrome (TS), is a common neuropsychiatric condition in children and teenagers. It is characterized by sudden, rapid, repetitive, and non-rhythmic movements (motor tics) or sounds (vocal tics), or both. TD is most common in school-aged children, typically starting between ages 3 and 15, with symptoms peaking around ages 10-12. Children with TD often experience other challenges like obsessive-compulsive behaviors (OCD), attention-deficit hyperactivity disorder (ADHD), autism spectrum traits, anxiety, depression, sleep issues, or self-harm. These challenges can significantly impact the child's life, family, and society, making TD a chronic and difficult-to-treat condition that affects young people's health and quality of life.

Current treatments mainly involve medications and behavioral therapy. Drugs are often the first choice and can help reduce core symptoms, but side effects, poor long-term adherence, and symptom relapse after stopping medication make many families hesitant to use them. Behavioral therapy has fewer side effects but requires long-term effort, works slowly, and may not suit younger children.

Traditional acupuncture has shown promise in treating childhood neuropsychiatric conditions. Research suggests acupuncture may help by regulating nervous system function, improving brain blood flow, and balancing brain chemicals. Recent studies on TD report that acupuncture might reduce tic frequency/severity, improve mood/behavior, and enhance daily life. However, reviews of existing research point out flaws like small study groups, poorly designed methods, and lack of proper control groups. These issues create uncertainty about acupuncture's true effectiveness for TD, highlighting the need for larger, better-designed studies to confirm its benefits.

In this 12-week, randomized, controlled trial with outcome assessor and data analyst blinding, a total of 136 children with chronic tic disorders (CTD) will be enrolled. Participants will be randomly allocated into two groups: 1) the scalp acupuncture group (n = 68), which will receive scalp acupuncture combined with conventional behavioral therapy (three sessions per week for 12 weeks), and 2) the routine intervention control group (n = 68), which will undergo behavioral therapy. Assessments will be conducted at baseline, weeks 4, 8, and 12 (treatment phase), and week 24 (follow-up phase) using the Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression (CGI) scale, Children and Adolescents' Quality of Life Scale for Gilles de la Tourette Syndrome (C\&A-GTS-QOL) and Child Behavior Checklist (CBCL).

The study will be conducted across five clinical centers: the Children's Hospital of Fudan University, Xiamen Children's Hospital, First People's Hospital of Zunyi, The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine and Dehong Prefecture People's Hospital.

Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria for Chronic Motor Tic Disorder or Vocal Tic Disorder as defined by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), confirmed by at least one associate chief psychiatrist. Tic severity must be mild to moderate (YGTSS total score ≤45).
2. Age: 4-13 years old.
3. Patients with comorbid conditions (e.g., ADHD, OCD, oppositional defiant disorder, depression, anxiety) must have stable medication regimens with no anticipated adjustments during the study period.
4. Patients currently taking traditional Chinese herbal medications or decoctions for tics must agree to discontinue use and complete a 2-4 week washout period before enrollment.
5. Newly diagnosed cases unwilling to start medication, patients with unsatisfactory medication-controlled tics, or those reporting significant side effects are eligible if tics have remained stable (unchanged for ≥2 months) without improvement.
6. Voluntary participation with a signed informed consent form.

Exclusion Criteria:

1. IQ（intelligence quotient） ≤80.
2. Severe cardiac, liver, kidney diseases, hyperthyroidism, or unstable vital signs.
3. Comorbid conditions such as intellectual disability, autism spectrum disorder, childhood schizophrenia, bipolar disorder, specific learning disorders, or epilepsy.
4. Patients currently taking traditional Chinese herbal medications or decoctions for tics who refuse to discontinue use.
5. Patients unable to tolerate acupuncture therapy.
6. Prior acupuncture treatment for tics proven ineffective.

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: Assessments will be conducted at baseline, during the treatment phase (weeks 4, 8, and 12), and during the follow-up phase (week 24).
Secondary outcomes:
measure: Clinical Global Impression (CGI) Scale
timeFrame: Assessments will be conducted at baseline, during the treatment phase (weeks 4, 8, and 12), and during the follow-up phase (week 24).
measure: Children and Adolescents Quality of Life Scale for Tourette Syndrome (C&A-GTS-QOL)
timeFrame: Assessments will be conducted at baseline, during the treatment phase (weeks 4, 8, and 12), and during the follow-up phase (week 24)
measure: Child Behavior Checklist (CBCL)
timeFrame: Assessments will be conducted at baseline, during the treatment phase (weeks 4, 8, and 12), and during the follow-up phase (week 24)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Hao Zhou, M.D.
role: PRINCIPAL_INVESTIGATOR
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