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

Overview

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 Tuina treatment to Tuina treatment to see if scalp acupuncture treatment works to treat scalp acupuncture. Participants will: * Receive scalp acupuncture treatment and Tuina treatment for 2 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 Tuina treatment (two sessions per week for 12 weeks), and 2) the routine intervention control group (n = 68), which will undergo Tuina treatment. 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.

Interventions

• Other Scalp Acupuncture Treatment
  Acupoint Selection: Baihui (GV20), Sishencong (EX-HN1), Frontal Midline Line (MS1), Vertex Midline Line (MS5), Lateral Line 1 of Vertex (MS7), Shenting (GV24), Yintang (EX-HN3), Shuaigu (GB8) Acupuncture Manipulation: Needles with a diameter of 0.18-0.35 mm and length of 13-25 mm are selected. After routine disinfection of the acupoint skin, the practitioner holds the micro-needle and quickly inserts it into the subcutaneous tissue at an insertion angle of 15°-30°, primarily using superficial
• Other Tuina Treatment Group
  Prescription: Spleen Meridian (Pi Jing), Small Heavenly Heart (Xiao Tianxin), Five Finger Joints (Wu Zhi Jie), Internal Bagua (Nei Bagua), Hand Yin-Yang (Shou Yin Yang), Upper Three Passes (Shang San Guan), Gushing Spring (Yongquan, KI-1), Leg Three Miles (Zusanli, ST-36) Manipulation Techniques Pushing/Kneading the Spleen Meridian (Tonifying Pi Jing): Tapping Small Heavenly Heart (Xiao Tianxin): Kneading the Five Finger Joints (Wu Zhi Jie): Moving the Internal Bagua (Nei Bagua): Separatin

Primary outcome measures

• Yale Global Tic Severity Scale (YGTSS) [Time frame: Assessments will be conducted at baseline, during the treatment phase (weeks 4, 8, and 12), and during the follow-up phase (week 24).]

Secondary outcome measures (3)

• Clinical Global Impression (CGI) Scale [Time frame: Assessments will be conducted at baseline, during the treatment phase (weeks 4, 8, and 12), and during the follow-up phase (week 24).]
• Children and Adolescents Quality of Life Scale for Tourette Syndrome (C&A-GTS-QOL) [Time frame: Assessments will be conducted at baseline, during the treatment phase (weeks 4, 8, and 12), and during the follow-up phase (week 24)]
• Child Behavior Checklist (CBCL) [Time frame: Assessments will be conducted at baseline, during the treatment phase (weeks 4, 8, and 12), and during the follow-up phase (week 24)]

Eligibility criteria

Inclusion criteria

• 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 ≤50).
• Age: 4-12 years old.
• 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.
• 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.
• 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.
• Voluntary participation with a signed informed consent form.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Children's Hospital, Fudan University — Shanghai

Publications

• Leckman JF. Tic disorders. BMJ. 2012 Jan 5;344:d7659. doi: 10.1136/bmj.d7659. No abstract available. PMID 22223834
• Oluwabusi OO, Parke S, Ambrosini PJ. Tourette syndrome associated with attention deficit hyperactivity disorder: The impact of tics and psychopharmacological treatment options. World J Clin Pediatr. 2016 Feb 8;5(1):128-35. doi: 10.5409/wjcp.v5.i1.128. eCollection 2016 Feb 8. PMID 26862512
• Knight T, Steeves T, Day L, Lowerison M, Jette N, Pringsheim T. Prevalence of tic disorders: a systematic review and meta-analysis. Pediatr Neurol. 2012 Aug;47(2):77-90. doi: 10.1016/j.pediatrneurol.2012.05.002. PMID 22759682
• Jiang Yanlin, Zhang Qiang, Zhai Rui, Peng Yaqi, Tai Ran, and Wang Junhong. Systematic Review on the Prevalence and Risk Factors of Tic Disorders in Chinese Children. Chinese Journal of Child Health Care. 2023; 31: 661-667.
• Yang C, Zhang L, Zhu P, Zhu C, Guo Q. The prevalence of tic disorders for children in China: A systematic review and meta-analysis. Medicine (Baltimore). 2016 Jul;95(30):e4354. doi: 10.1097/MD.0000000000004354. PMID 27472724
• Liu ZS, Cui YH, Sun D, Lu Q, Jiang YW, Jiang L, Wang JQ, Luo R, Fang F, Zhou SZ, Wang Y, Cai FC, Lin Q, Xiong L, Zheng Y, Qin J. Current Status, Diagnosis, and Treatment Recommendation for Tic Disorders in China. Front Psychiatry. 2020 Aug 13;11:774. doi: 10.3389/fpsyt.2020.00774. eCollection 2020. PMID 32903695
• Yang C, Cheng X, Zhang Q, Yu D, Li J, Zhang L. Interventions for tic disorders: An updated overview of systematic reviews and meta analyses. Psychiatry Res. 2020 May;287:112905. doi: 10.1016/j.psychres.2020.112905. Epub 2020 Mar 1. PMID 32163785
• Pringsheim T, Okun MS, Muller-Vahl K, Martino D, Jankovic J, Cavanna AE, Woods DW, Robinson M, Jarvie E, Roessner V, Oskoui M, Holler-Managan Y, Piacentini J. Practice guideline recommendations summary: Treatment of tics in people with Tourette syndrome and chronic tic disorders. Neurology. 2019 May 7;92(19):896-906. doi: 10.1212/WNL.0000000000007466. PMID 31061208

Identifiers

NCT: NCT06924918 · CHFudanU2025-29

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗