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Clinical Trials in China / NCT07854665
Starting soon Not applicable

Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents

NCT07854665 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University
Phase
Not applicable
Started
2026-10-31
Last updated
2026-10-28

Condition(s) studied

Tourette SyndromeChronic Tic Disorder

Investigational drug(s) / intervention(s)

Transcutaneous auricular vagus nerve stimulationSham stimulation

Transcutaneous auricular vagus nerve stimulation: Participants in the transcutaneous auricular vagus nerve stimulation group will receive stimulation at auricular acupoints located within the distribution area of the vagus nerve. A Hwato SDZ-II B electroacupuncture apparatus will be employed, with the two connecting clips of the same output lead attached to the acupoints on the same side. Disperse-dense wave stimulation will be applied, with the intensity adjusted according to the patient's tolerance, and each session will last 30 minutes.

Sham stimulation: Participants in the sham group will receive electrical stimulation at auricular acupoints located outside the distribution area of the vagus nerve, with a current intensity of 0.1 mA. All other procedures will be identical to those of the treatment group.

Study summary

The objective of this trial is to evaluate the effect of transcutaneous auricular vagus nerve stimulation compared to sham stimulation in improving chronic tic disorder or Tourette's syndrome in children and adolescents.

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria 1. Meets the DSM-5 diagnostic criteria for Tourette syndrome or chronic motor or vocal tic disorder; 2. Age ≥6 and \<18 years; 3. YGTSS-TTS \>15, or \>10 for participants with motor tics or vocal tics only; 4. If the participant is taking medication at enrollment, the medication regimen and dosage must have been stable for at least 4 weeks, with no planned changes in medication or dosage during the study; 5. Has not received any non-pharmacological treatment for tics (e.g., acupuncture, transcranial magnetic stimulation, deep brain stimulation) within the preceding 8 weeks; 6. Provides written informed consent. Exclusion Criteria 1. Mental or cognitive disability that would preclude participation in the study; 2. Ear skin lesions, such as infection or eczema; 3. An implanted cardiac pacemaker or other electronic medical device; 4. Severe physical diseases, such as coronary heart disease, malignancy, or renal failure; 5. Current participation in another clinical trial.

Primary outcome measure(s)

  • The Yale Global Tic Severity Scale Total Tic Score — Week 8 (post treatment).
    The Yale Global Tic Severity Scale (YGTSS) is a clinician-rated instrument designed to evaluate the severity of motor tics, phonic tics, and overall impairment over the preceding week. Motor and vocal tics are rated independently across five dimensions (number, frequency, intensity, complexity, and interference; range 0-5 each), and the dimension scores are summed to yield separate Motor and Vocal Tic scores (range 0-25 each) as well as a combined YGTSS Total Tic Score (range 0-50), with higher scores indicating greater tic severity. The YGTSS Impairment Rating captures tic-related distress and functional impact (range 0-50). The YGTSS Total Tic Score and the YGTSS Impairment Rating are summed to produce a YGTSS total score (range 0-100), with higher scores indicating greater overall severity.

Trial sites (1)

FacilityCityRegionStatus
The first Affiliated Hospital of Zhejiang Chinese Medical University (FirstZhejiangCMU) Hangzhou Zhejiang

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Other trials for the same condition

Effect of RNS in Treatment-refractory Tourette's Syndrome Recruiting
Multitarget Stereotactic Electrophysiological Recording and Stimulation for Tourette Syndrome Recruiting
Washed Microbiota Transplantation for Tourette's Syndrome Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07854665 on ClinicalTrials.gov ↗ ← All trials in China