Status:
ENROLLING_BY_INVITATION
Scalp Acupuncture Treatment for Chronic Tic Disorders in Children
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Tic Disorder
Eligibility:
All Genders
4-12 years
Phase:
NA
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...
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 teena...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT06924918
Start Date
August 1 2025
End Date
April 30 2027
Last Update
July 23 2025
Active Locations (1)
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1
Children's Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 201102