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Search / Trial NCT06924918

Scalp Acupuncture Treatment for Chronic Tic Disorders in Children

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Apr 5, 2025

Trial Information

Current as of July 01, 2025

Enrolling by invitation

Keywords

Tic Disorder Scalp Acupuncture Treatment Multicenter Randomized Controlled Trial

ClinConnect Summary

This clinical trial is looking at whether scalp acupuncture can help children with chronic tic disorders, which are repeated movements or sounds that some kids struggle to control. The researchers want to find out if this treatment can make symptoms better, improve how kids interact with others, and overall enhance their quality of life. To do this, they will compare the effects of scalp acupuncture along with behavioral therapy to just behavioral therapy alone.

To be eligible for this study, children must be between 4 and 13 years old and have a diagnosed tic disorder that is mild to moderate in severity. They should not have any serious health issues or conditions that could complicate the treatment, and they must be willing to stop any current herbal treatments for tics before joining the trial. Participants will attend treatment sessions three times a week for 12 weeks and will complete surveys to track their progress. It’s important to know that this trial is not yet recruiting participants, but it aims to provide valuable insights into the effectiveness and safety of scalp acupuncture for children with tic disorders.

Gender

ALL

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.

About Children's Hospital Of Fudan University

The Children's Hospital of Fudan University is a leading pediatric healthcare institution in China, renowned for its commitment to advancing child health through innovative research and clinical excellence. As a prominent clinical trial sponsor, the hospital focuses on conducting high-quality, ethically-driven studies that aim to improve pediatric care and treatment outcomes. With a multidisciplinary team of experienced healthcare professionals and researchers, the hospital leverages its robust infrastructure and expertise to facilitate groundbreaking clinical trials, ensuring the safety and well-being of child participants while contributing valuable insights to the global medical community.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Hao Zhou, M.D.

Principal Investigator

Children's Hospital of Fudan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported