Acupuncture Treament in Children With Tic Disorders
8. mai 2026 oppdatert av: Meizhou People's Hospital
Efficacy and Safety of Acupuncture in the Treatment of Tic Disorders in Children, Based on MR-DTI
This study intends to evaluate the efficacy of acupuncture on tic disorders in Children; and to explore the underlying mechanism of acupuncture intervention on tic disorders based on Magnetic Resonance Diffusion Tensor Imaging(MR-DTI).
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
102
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Zhongtao Song, PhD
- Telefonnummer: 0086-19820151649
- E-post: songzhongtao1@mzrmyy.com
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
- Barn
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Must meet the diagnostic criteria for Provisional Tic Disorder (PTD) or Persistent (Chronic) Motor or Vocal Tic Disorder (CTD)
- Right-handed children aged 5-18 years
- Have not previously received systematic acupuncture treatment and are able to adhere to acupuncture treatment for ≥ 2 months
- Complete medical records available
- Not currently participating in any other clinical study
- Voluntary participants, with the signature and consent of their guardians, and children aged 8 and above obtaining their own informed consent
Exclusion Criteria:
- History of hepatolenticular degeneration (Wilson's disease), rheumatic chorea, childhood migraine, epilepsy, intellectual disability, schizophrenia, or other related conditions
- Presence of organic neurological diseases or other severe conditions significantly impacting quality of life
- Recent use of centrally-acting medications
- Inability to regularly complete the acupuncture treatment regimen
- Inability to undergo the MR-DTI examination
- Refusal to sign the written informed consent form
- Inability of the child or guardian to cooperate during the treatment and follow-up process
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: Acupuncture group
Behavioral intervention and acupuncture
|
The Acupuncture point prescription is as follows: Sishencong (EX-HN1), bilateral Shuaigu (GB8), bilateral Yangbai (GB14), bilateral Sibai (ST2), bilateral Fengchi (GB20), bilateral Fenglong (ST40), bilateral Hegu (LI4), and bilateral Taichong (LR3).
Points will be selected based on Traditional Chinese Medicine syndrome differentiation, with location standardized according to the 2006 National Standard of the People's Republic of China (GB/T 12346-2006), "Nomenclature and Location of Acupuncture Points."
After routine skin disinfection, Sishencong will be obliquely needled to a depth of 0.5 cun, and the remaining points will be perpendicularly needled to a depth of 1 cun.
The twirling manipulation will be applied until the needling sensation (Deqi) is locally achieved.
Needles will be retained for 30 minutes.
Treatment will be administered once daily, 5 times per week, for a total of 8 weeks (40 sessions).
Comprehensive Behavioral Intervention for Tics (CBIT) is recommended as a first-line intervention by organizations such as the American Academy of Neurology.It consists of several core components: Psychoeducation,Awareness Training,Competing Response Training,Function-Based Intervention and Social Support and Relapse Prevention
|
|
Annen: Waiting for acupuncture group
Behavioral intervention
|
Comprehensive Behavioral Intervention for Tics (CBIT) is recommended as a first-line intervention by organizations such as the American Academy of Neurology.It consists of several core components: Psychoeducation,Awareness Training,Competing Response Training,Function-Based Intervention and Social Support and Relapse Prevention
|
|
Ingen inngripen: Healthy control group
Healthy participants without intervention
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Yale Global Tic Severity Scal(YGTSS)
Tidsramme: baseline,4 weeks,8 weeks,6 months
|
The Yale Global Tic Severity Scale (YGTSS) Score is designed to assess the severity of symptoms in children with TD by scoring the type of tics, frequency of tics, intensity of tics, complexity of tics, degree of interference with normal behavior, and degree of impairment of social functioning in the child, with a total score ranging from 0-75, with higher scores indicating greater severity of the child's condition.
|
baseline,4 weeks,8 weeks,6 months
|
|
MR-DTI
Tidsramme: baseline,8 weeks
|
Magnetic Resonance Diffusion Tensor Imaging(MR-DTI).Scanning will employ a single-shot echo-planar imaging sequence with 15 diffusion gradient directions.
Software such as DTI Studio will be used to calculate the Mean Diffusivity (MD), Fractional Anisotropy (FA), and Apparent Diffusion Coefficient (ADC) values for each subject's corpus callosum, bilateral globus pallidus, thalamus, putamen, and caudate nucleus.
|
baseline,8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pediatric quality of life inventory
Tidsramme: baseline,4 weeks,8 weeks,6 months
|
Pediatric quality of life inventory 4.0(PedsQL 4.0) is composed of 23 items comprising 4 dimensions: : 1) Physical Functioning (8 items), 2) Emotional Functioning (5 items), 3) Social Functioning (5 items), and 4) School Functioning (5 items).
Higher scores indicate better HRQOL with a range of 0-100.
|
baseline,4 weeks,8 weeks,6 months
|
|
Traditional Chinese Medicine Symptom Score
Tidsramme: baseline,4 weeks,8 weeks,6 months
|
Traditional Chinese medicine symptom score is used to assess overall health status, including aspects such as mood, appearance, sleep, diet, and gastrointestinal function.
Higher scores indicate more severe symptoms with a range of 0-100.
|
baseline,4 weeks,8 weeks,6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acupuncture-Related Adverse Events
Tidsramme: 8 weeks
|
All adverse events occurring during the intervention will be recorded
|
8 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
1. juni 2026
Primær fullføring (Antatt)
1. mai 2029
Studiet fullført (Antatt)
1. mai 2030
Datoer for studieregistrering
Først innsendt
29. april 2026
Først innsendt som oppfylte QC-kriteriene
8. mai 2026
Først lagt ut (Faktiske)
15. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MZPH202604001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .