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

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

124

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310000
        • The first Affiliated Hospital of Zhejiang Chinese Medical University (FirstZhejiangCMU)
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Simeng Wang, PHD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Transcutaneous auricular vagus nerve stimulation

Participants will receive transcutaneous auricular vagus nerve stimulation five times per week for eight consecutive weeks.

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 Comparator: Sham stimulation

Participants will receive sham stimulation five times per week for eight consecutive weeks.

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The Yale Global Tic Severity Scale Total Tic Score
Tidsram: 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.

Week 8 (post treatment).

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The Yale Global Tic Severity Scale Total Score
Tidsram: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).

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.

Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Children's Yale-Brown Obsessive Compulsive Scale
Tidsram: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).

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.

Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Swanson, Nolan, and Pelham-IV-18
Tidsram: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).

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.

Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life
Tidsram: Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).

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.

Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adverse Events
Tidsram: Week 0 (baseline) to week 12.

An adverse event is any unexpected symptom, sign, or health condition occurring after initiation of study treatment, which may or may not be related to the study intervention. Pre-existing health conditions or diseases will only be considered as adverse events if they worsen after enrollment.

Week 0 (baseline) to week 12.

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

31 oktober 2026

Primärt slutförande (Beräknad)

31 oktober 2027

Avslutad studie (Beräknad)

31 oktober 2027

Studieregistreringsdatum

Först inskickad

27 september 2026

Först inskickad som uppfyllde QC-kriterierna

27 september 2026

Första postat (Faktisk)

2 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Deidentified participant data will be available from the study PI upon reasonable request after publication.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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