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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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

124

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310000
        • The first Affiliated Hospital of Zhejiang Chinese Medical University (FirstZhejiangCMU)
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Simeng Wang, PHD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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-komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Yale Global Tic Severity Scale Total Tic Score
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Yale Global Tic Severity Scale Total Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adverse Events
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

31. oktober 2026

Primær fullføring (Antatt)

31. oktober 2027

Studiet fullført (Antatt)

31. oktober 2027

Datoer for studieregistrering

Først innsendt

27. september 2026

Først innsendt som oppfylte QC-kriteriene

27. september 2026

Først lagt ut (Faktiske)

2. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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