Tourette SyndromeNCT07854665
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
A study testing Transcutaneous auricular vagus nerve stimulation in people with Tourette Syndrome and Chronic Tic Disorder, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Tourette Syndrome, Chronic Tic Disorder
- What is being tested?
- Transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meets the DSM-5 diagnostic criteria for Tourette syndrome or chronic motor or vocal tic disorder;
- Age ≥6 and <18 years;
- YGTSS-TTS >15, or >10 for participants with motor tics or vocal tics only;
- 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;
- Has not received any non-pharmacological treatment for tics (e.g., acupuncture, transcranial magnetic stimulation, deep brain stimulation) within the preceding 8 weeks;
- Provides written informed consent.
Who cannot join
- Mental or cognitive disability that would preclude participation in the study;
- Ear skin lesions, such as infection or eczema;
- An implanted cardiac pacemaker or other electronic medical device;
- Severe physical diseases, such as coronary heart disease, malignancy, or renal failure;
- Current participation in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The first Affiliated Hospital of Zhejiang Chinese Medical University (FirstZhejiangCMU)
Hangzhou, Zhejiang, 310000
Simeng Wang, PHD, 8618811022134, 18811022134@163.com
Zhiyi Xiong, PHD, 8618811022104, zhiyixiong@foxmail.com
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents: A Randomized Controlled Clinical Trial
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.
Read the detailed description
Participants will be randomly assigned to receive transcutaneous auricular vagus nerve stimulation or sham stimulation. Both interventions will be administered 5 times per week for 8 weeks. Study outcomes will be evaluated at baseline and at weeks 4, 8, and 12.
- Conditions
- Tourette Syndrome, Chronic Tic Disorder
- Being tested
- Transcutaneous auricular vagus nerve stimulation, Sham stimulation
- Keywords
- Transcutaneous Auricular Vagus Nerve Stimulation, Randomized Controlled Trial, Tourette syndrome, Chronic Tic Disorder
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular vagus nerve stimulationDevice
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 stimulationDevice
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 group | Role | What they receive |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation | Experimental | Participants will receive transcutaneous auricular vagus nerve stimulation five times per week for eight consecutive weeks. Receives: Device: Transcutaneous auricular vagus nerve stimulation |
| Sham stimulation | Sham comparator | Participants will receive sham stimulation five times per week for eight consecutive weeks. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Yale Global Tic Severity Scale Total Tic Score
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.
Measured: Week 8 (post treatment).
Secondary outcomes (4)
The Yale Global Tic Severity Scale Total Score
The Yale Global Tic Severity Scale (YGTSS) is a clinician-rated instrument assessing motor tics, vocal tics, and impairment over the preceding week. Motor and vocal tics are each rated on five dimensions (number, frequency, intensity, complexity, and interference; 0-5 each), yielding Motor and Vocal Tic scores (0-25 each) and a YGTSS Total Tic Score (0-50). The YGTSS Impairment (0-50) is added to the YGTSS Total Tic Score to produce a YGTSS Total Score (0-100), with higher scores indicating greater severity.
Measured: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Children's Yale-Brown Obsessive Compulsive Scale
The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) will be used to assess the severity of obsessive-compulsive symptoms in children and adolescents. The total score of CY-BOCS ranges from 0 to 40, with higher scores indicate greater symptom severity.
Measured: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Swanson, Nolan, and Pelham-IV-18
The Swanson, Nolan, and Pelham Rating Scale version IV (SNAP-IV-18) will be used to assess symptoms of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. The total score of SNAP-IV-18 ranges from 0 to 54, with higher scores indicate more severe symptoms.
Measured: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life
The Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life (C\&A-GTS-QOL) questionnaire will be used to assess health-related quality of life in children and adolescents with Tourette syndrome. The total score of C\&A-GTS-QOL is typically transformed to a 0-100 scale, with higher scores indicating greater impairment and poorer quality of life.
Measured: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WangSimeng, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854665
- Sponsor's protocol ID
- FirstZhejiangCMU
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be available from the study PI upon reasonable request after publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07854665
- Acronym / sponsor ID
- FirstZhejiangCMU
- Conditions
- Tourette Syndrome, Chronic Tic Disorder
- Keywords
- Transcutaneous Auricular Vagus Nerve Stimulation, Randomized Controlled Trial, Tourette syndrome, Chronic Tic Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be randomly assigned to receive transcutaneous auricular vagus nerve stimulation or sham stimulation. Both interventions will be administered 5 times per week for 8 weeks. Study outcomes will be evaluated at baseline and at weeks 4, 8, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation | Experimental | Device: Transcutaneous auricular vagus nerve stimulationParticipants will receive transcutaneous auricular vagus nerve stimulation five times per week for eight consecutive weeks. |
| Sham stimulation | Sham comparator | Device: Sham stimulationParticipants will receive sham stimulation five times per week for eight consecutive weeks. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Meets the DSM-5 diagnostic criteria for Tourette syndrome or chronic motor or vocal tic disorder;
- Age ≥6 and <18 years;
- YGTSS-TTS >15, or >10 for participants with motor tics or vocal tics only;
- 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;
- Has not received any non-pharmacological treatment for tics (e.g., acupuncture, transcranial magnetic stimulation, deep brain stimulation) within the preceding 8 weeks;
Key exclusion criteria (5 listed)
- Mental or cognitive disability that would preclude participation in the study;
- Ear skin lesions, such as infection or eczema;
- An implanted cardiac pacemaker or other electronic medical device;
- Severe physical diseases, such as coronary heart disease, malignancy, or renal failure;
- Current participation in another clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulationParticipants 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. | Device | Transcutaneous auricular vagus nerve stimulation |
| Sham stimulationParticipants 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. | Device | Sham stimulation |
Primary outcome
The Yale Global Tic Severity Scale Total Tic Score
Time frame: 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.
4 secondary outcomes
The Yale Global Tic Severity Scale Total Score
Time frame: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Children's Yale-Brown Obsessive Compulsive Scale
Time frame: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Swanson, Nolan, and Pelham-IV-18
Time frame: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life
Time frame: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be available from the study PI upon reasonable request after publication.
Related trials for Tourette Syndrome
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
Tourette Syndrome in Children
Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome
RecruitingPhase 2
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
Neurodevelopmental Disorders, Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous auricular vagus nerve stimulation in people with Tourette Syndrome and Chronic Tic Disorder, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simeng Wang, PHD (8618811022134, 18811022134@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Yale Global Tic Severity Scale Total Tic Score (time frame: Week 8 (post treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.