Scalp Acupuncture Treatment for Chronic Tic Disorders in Children

NCT06924918 | Enrolling By Invitation DMC

• 1 other identifier: CHFudanU2025-29
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Tic Disorder

Keywords

Tic Disorder; scalp acupuncture treatment; Multicenter Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Scale (YGTSS)

  Yale Global Tic Severity Scale (YGTSS) is a standardized instrument designed to assess the severity of tic disorders. It evaluates motor tics and vocal tics separately across five dimensions: frequency, intensity, complexity, interference, and overall severity, with each dimension scored on a scale of 0-5 points. The total scores for motor and vocal tics range from 0-25 points each. Additionally, the YGTSS assesses the overall functional impairment caused by tics in daily life, social interactions, academic performance, and occupational activities, with impairment scores ranging from 0-50 points. Total YGTSS Score is calculated as the sum of motor tic score, vocal tic score, and functional impairment score, yielding a composite score of 0-100 points, where higher scores indicate greater symptom severity.

  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 (3)

• Clinical Global Impression (CGI) Scale

  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)

  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)

  Assessments will be conducted at baseline, during the treatment phase (weeks 4, 8, and 12), and during the follow-up phase (week 24)

Study Arms (2)

Scalp Acupuncture Treatment Group

EXPERIMENTAL

This group will receive scalp acupuncture treatment combined with Tuina treatment. The scalp acupuncture treatment and Tuina treatment will be implemented two times a week, eight times per treatment course, with each patient having three treatment courses in total.

Other: Scalp Acupuncture Treatment; Other: Tuina Treatment Group

Tuina Treatment Group

ACTIVE COMPARATOR

This group will receive Tuina treatment only. The Tuina treatment will be implemented two times a week, eight times per treatment course, with each patient having three treatment courses in total.

Other: Tuina Treatment Group

Interventions

Scalp Acupuncture Treatment OTHER

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 horizontal insertion. The insertion depth is maintained at 15-20 mm, adjusted according to the child's head circumference, body size, and body mass. Needles are retained for 30 minutes. Course of treatment: 2 times a week for 12 weeks

Scalp Acupuncture Treatment Group

Tuina Treatment Group OTHER

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): Separating Yin and Yang (Separating Shou Yin Yang): Pushing Up the Upper Three Passes (Pushing San Guan): Kneading Gushing Spring (Yongquan, KI-1): Kneading Leg Three Miles (Zusanli, ST-36): 2 times a week for 12 weeks

Scalp Acupuncture Treatment Group; Tuina Treatment Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital, Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (10)

• Leckman JF. Tic disorders. BMJ. 2012 Jan 5;344:d7659. doi: 10.1136/bmj.d7659. No abstract available.

  PMID: 22223834 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Kim DD, Barr AM, Chung Y, Yuen JWY, Etminan M, Carleton BC, White RF, Honer WG, Procyshyn RM. Antipsychotic-Associated Symptoms of Tourette Syndrome: A Systematic Review. CNS Drugs. 2018 Oct;32(10):917-938. doi: 10.1007/s40263-018-0559-8.

  PMID: 30121819 BACKGROUND

• Roessner V, Eichele H, Stern JS, Skov L, Rizzo R, Debes NM, Nagy P, Cavanna AE, Termine C, Ganos C, Munchau A, Szejko N, Cath D, Muller-Vahl KR, Verdellen C, Hartmann A, Rothenberger A, Hoekstra PJ, Plessen KJ. European clinical guidelines for Tourette syndrome and other tic disorders-version 2.0. Part III: pharmacological treatment. Eur Child Adolesc Psychiatry. 2022 Mar;31(3):425-441. doi: 10.1007/s00787-021-01899-z. Epub 2021 Nov 10.

  PMID: 34757514 BACKGROUND

MeSH Terms

Conditions

Tic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hao Zhou, M.D.

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department

Model Details: This is an outcome assessor and data analyst-blinded, randomized, controlled superiority trial.

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: April 13, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available for sharing for one year following the publication of the research results as a peer-reviewed paper.
• Access Criteria: Data will be available for non-commercial research upon reasonable request to the corresponding author, subject to a signed data use agreement and ethical compliance. Sharing is limited to 1 year post-publication.

Locations

CN (1)