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

NCT07854665 | Not Yet Recruiting

• 1 other identifier: FirstZhejiangCMU
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Tic Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Scale Total Tic Score

  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 (5)

• Change in YGTSS-TTS score from baseline

  week 4,week12

• Change in YGTSS scores across other dimensions relative to baseline

  week 4,week 8,week 12

• Children's Yale-Brown Obsessive Compulsive Scale

  Week 0, Week 4, Week 8, Week 12

• Swanson, Nolan, and Pelham-IV-18

  Week 0, Week 4, Week 8, Week 12

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

  Week 0, Week 4, Week 8, Week 12

Study Arms (2)

Transcutaneous Auricular Point Electrical Stimulation

EXPERIMENTAL

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

micro-stimulation

SHAM COMPARATOR

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

Transcutaneous Auricular Point Electrical Stimulation DEVICE

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.

Transcutaneous Auricular Point Electrical Stimulation; micro-stimulation

micro-stimulation DEVICE

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.

Transcutaneous Auricular Point Electrical Stimulation; micro-stimulation

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• （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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead
• Zhejiang Provincial Tongde Hospital: collaborator

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Tic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Simeng Wang, PHD

CONTACT

8618811022134; 18811022134@163.com

Zhiyi Xiong, PHD

CONTACT

8618811022104; zhiyixiong@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

CN (1)