CClinicalTrials.gg
Not yet recruitingNCT07854665Updated Oct 2, 2026

A Randomized Controlled Clinical Trial of Transcutaneous Auricular Point Electrical Stimulation for Improving Symptoms of Chronic Tic Disorders in Children/Adolescents

An interventional study of Transcutaneous Auricular Point Electrical Stimulation and micro-stimulation in Tic Disorder, sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University. Not yet recruiting at 1 site in China. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University · Not applicable, Interventional, and Treatment

Updated Oct 2, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study summary

The objective of this trial is to evaluate the effect of transcutaneous auricular point electrical stimulation compared to the micro-stimulation in the treatment of chronic tic disorder in adolescents

Read the detailed description

Participants will be randomly assigned to receive transcutaneous auricular point electrical stimulation or micro-stimulation treatment. Both treatments will be administered 5 times per week, starting from the time of enrollment and lasting for 8 weeks. The study outcomes will be evaluated at four time points: baseline (Week 0), during treatment (Week 4), and after treatment (Week 8), with a follow-up period of 4 weeks after the end of treatment (Week 12).

02

Conditions studied

  • Tic Disorder

Browse trials for

Keywords

  • Tic Disorder
  • Transcutaneous Auricular Point Electrical Stimulation
  • Transcutaneous Auricular Vagus Nerve Stimulation
  • Randomized Controlled Trial
  • Placebo
03

In context

Tic Disorders

98 studies on the registry are indexed under Tic Disorders; 23 are open to participants now.

This study's planned enrollment of 124 is above the median of 50 across 80 interventional studies indexed under Tic Disorders.

Browse Tic Disorders studies →

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University is the lead sponsor of 37 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

(1)Meet DSM-5 diagnostic criteria for Tourette syndrome or persistent (chronic) motor or vocal tic disorder; (2) Age between 6 and 18 years, regardless of gender; (3) YGTSS-TTS score >15; for participants with only motor or vocal tics, a YGTSS-TTS score >10 is required; (4) If currently on medication, the dosage of tic-related medications must have been stable for the past 4 weeks, and no changes to medication are planned during the study period; (5) No physical therapy or surgical treatment for this condition within the past 8 weeks; (6) The participant's guardian signs an informed consent form, and participants aged 8 years and older sign an appropriate assent document, voluntarily agreeing to participate in the study.

Exclusion criteria

Exclusion Criteria:

(1) Presence of severe mental disorders, such as schizophrenia, bipolar disorder, severe depression, suicide risk, etc., or severe cognitive dysfunction, making it impossible to cooperate with the study; (2) Skin damage, infection, eczema, etc. in the ear area, making treatment impossible; (3) Implanted with cardiac pacemaker, implantable nerve stimulator or other electronic implant devices; (4) Complicated with severe cardiovascular or other important organ diseases; (5) Currently participating in other clinical studies.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    Transcutaneous Auricular Point Electrical Stimulation

    After skin disinfection, the connecting clip is fixed to the Auricular Point, an electroacupuncture apparatus will be connected. The stimulation parameters will be sparse and dense waves, 4/20Hz (4Hz for 5 seconds, 20Hz for 10 seconds, alternating); the pulse width is 0.2ms ± 30%, and the current intensity will be adjusted according to the participant's comfort level.

    Device: Transcutaneous Auricular Point Electrical Stimulation · Device: micro-stimulation

  • Sham comparator
    micro-stimulation

    After skin disinfection, the connecting clip is fixed to the Auricular Point, an electroacupuncture apparatus will be connected. The stimulation parameters will be sparse and dense waves, 4/20Hz (4Hz for 5 seconds, 20Hz for 10 seconds, alternating); the pulse width is 0.2ms ± 30%, and the current intensity will be adjusted according to the participant's comfort level.

    Device: Transcutaneous Auricular Point Electrical Stimulation · Device: micro-stimulation

Interventions

  • DeviceTranscutaneous Auricular Point Electrical Stimulation

    Participants in the Transcutaneous Auricular Point Electrical Stimulation group will receive Transcutaneous Auricular Point Electrical Stimulation 5 a week, with each session lasting 30 minutes. The treatment will start from the time of enrollment and lasting for 8 weeks.

  • Devicemicro-stimulation

    Participants in the Transcutaneous Auricular Point Electrical Stimulation group will receive Transcutaneous Auricular Point Electrical Stimulation 5 a week, with each session lasting 30 minutes. The treatment will start from the time of enrollment and lasting for 8 weeks.

06

What researchers measure

Primary outcomes

  1. Yale Global Tic Severity Scale Total Tic Score

    Time frame: baseline (Week 0), during treatment (Week 4), and after treatment (Week 8), with a follow-up period of 4 weeks after the end of treatment (Week 12)

Secondary outcomes

  1. Change in YGTSS-TTS score from baseline

    Time frame: week 4,week12

  2. Change in YGTSS scores across other dimensions relative to baseline

    Time frame: week 4,week 8,week 12

  3. Children's Yale-Brown Obsessive Compulsive Scale

    Time frame: Week 0, Week 4, Week 8, Week 12

  4. Swanson, Nolan, and Pelham-IV-18

    Time frame: Week 0, Week 4, Week 8, Week 12

  5. Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life

    Time frame: Week 0, Week 4, Week 8, Week 12

07

Study locations

1 site
  • The first Affiliated Hospital of Zhejiang Chinese Medical University (FirstZhejiangCMU)
    Hangzhou, Zhejiang 310000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07854665
Lead sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University
Collaborators
Zhejiang Provincial Tongde Hospital
Responsible party
Sponsor
First posted
Oct 2, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Jul 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Oct 2, 2026

Study contacts

Simeng Wang, PHD
Contact
18811022134@163.com
8618811022134 ext. zhiyixiong@fox
Zhiyi Xiong, PHD
Contact
zhiyixiong@foxmail.com
8618811022104

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion