Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT06924918
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-23
First Post:
2025-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Scalp Acupuncture Treatment for Chronic Tic Disorders in Children
Sponsor:
Children's Hospital of Fudan University
Organization:
Study Overview
Official Title:
Scalp Acupuncture Treatment for Chronic Tic Disorders in Children: A Multicenter Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if scalp acupuncture works to treat chronic tic disorders (CTD) in children. It will also learn about the safety of scalp acupuncture. The main questions it aims to answer are:
* Does scalp acupuncture improve clinical symptoms and social functioning, and enhance quality of life in children with chronic tic disorders?
* Researchers will compare scalp acupuncture combined with Tuina treatment to Tuina treatment to see if scalp acupuncture treatment works to treat scalp acupuncture.
Participants will:
* Receive scalp acupuncture treatment and Tuina treatment for 2 times per week and last for 12 weeks.
* Receive questionnaire survey using the following scales: the Yale Global Tic Severity Scale (YGTSS), the Clinical Global Impression (CGI) Scale, the Children and Adolescents Quality of Life Scale for Tourette Syndrome (C\&A-GTS-QOL) and the Child Behavior Checklist (CBCL).
* Does scalp acupuncture improve clinical symptoms and social functioning, and enhance quality of life in children with chronic tic disorders?
* Researchers will compare scalp acupuncture combined with Tuina treatment to Tuina treatment to see if scalp acupuncture treatment works to treat scalp acupuncture.
Participants will:
* Receive scalp acupuncture treatment and Tuina treatment for 2 times per week and last for 12 weeks.
* Receive questionnaire survey using the following scales: the Yale Global Tic Severity Scale (YGTSS), the Clinical Global Impression (CGI) Scale, the Children and Adolescents Quality of Life Scale for Tourette Syndrome (C\&A-GTS-QOL) and the Child Behavior Checklist (CBCL).
Detailed Description:
Tourette Disorder (TD), which includes Temporary Tic Disorder (TTD), Chronic Motor or Vocal Tic Disorder (CTD), and Tourette Syndrome (TS), is a common neuropsychiatric condition in children and teenagers. It is characterized by sudden, rapid, repetitive, and non-rhythmic movements (motor tics) or sounds (vocal tics), or both. TD is most common in school-aged children, typically starting between ages 3 and 15, with symptoms peaking around ages 10-12. Children with TD often experience other challenges like obsessive-compulsive behaviors (OCD), attention-deficit hyperactivity disorder (ADHD), autism spectrum traits, anxiety, depression, sleep issues, or self-harm. These challenges can significantly impact the child's life, family, and society, making TD a chronic and difficult-to-treat condition that affects young people's health and quality of life.
Current treatments mainly involve medications and behavioral therapy. Drugs are often the first choice and can help reduce core symptoms, but side effects, poor long-term adherence, and symptom relapse after stopping medication make many families hesitant to use them. Behavioral therapy has fewer side effects but requires long-term effort, works slowly, and may not suit younger children.
Traditional acupuncture has shown promise in treating childhood neuropsychiatric conditions. Research suggests acupuncture may help by regulating nervous system function, improving brain blood flow, and balancing brain chemicals. Recent studies on TD report that acupuncture might reduce tic frequency/severity, improve mood/behavior, and enhance daily life. However, reviews of existing research point out flaws like small study groups, poorly designed methods, and lack of proper control groups. These issues create uncertainty about acupuncture's true effectiveness for TD, highlighting the need for larger, better-designed studies to confirm its benefits.
In this 12-week, randomized, controlled trial with outcome assessor and data analyst blinding, a total of 136 children with chronic tic disorders (CTD) will be enrolled. Participants will be randomly allocated into two groups: 1) the scalp acupuncture group (n = 68), which will receive scalp acupuncture combined with Tuina treatment (two sessions per week for 12 weeks), and 2) the routine intervention control group (n = 68), which will undergo Tuina treatment. Assessments will be conducted at baseline, weeks 4, 8, and 12 (treatment phase), and week 24 (follow-up phase) using the Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression (CGI) scale, Children and Adolescents' Quality of Life Scale for Gilles de la Tourette Syndrome (C\&A-GTS-QOL) and Child Behavior Checklist (CBCL).
The study will be conducted across five clinical centers: the Children's Hospital of Fudan University, Xiamen Children's Hospital, First People's Hospital of Zunyi, The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine and Dehong Prefecture People's Hospital.
Current treatments mainly involve medications and behavioral therapy. Drugs are often the first choice and can help reduce core symptoms, but side effects, poor long-term adherence, and symptom relapse after stopping medication make many families hesitant to use them. Behavioral therapy has fewer side effects but requires long-term effort, works slowly, and may not suit younger children.
Traditional acupuncture has shown promise in treating childhood neuropsychiatric conditions. Research suggests acupuncture may help by regulating nervous system function, improving brain blood flow, and balancing brain chemicals. Recent studies on TD report that acupuncture might reduce tic frequency/severity, improve mood/behavior, and enhance daily life. However, reviews of existing research point out flaws like small study groups, poorly designed methods, and lack of proper control groups. These issues create uncertainty about acupuncture's true effectiveness for TD, highlighting the need for larger, better-designed studies to confirm its benefits.
In this 12-week, randomized, controlled trial with outcome assessor and data analyst blinding, a total of 136 children with chronic tic disorders (CTD) will be enrolled. Participants will be randomly allocated into two groups: 1) the scalp acupuncture group (n = 68), which will receive scalp acupuncture combined with Tuina treatment (two sessions per week for 12 weeks), and 2) the routine intervention control group (n = 68), which will undergo Tuina treatment. Assessments will be conducted at baseline, weeks 4, 8, and 12 (treatment phase), and week 24 (follow-up phase) using the Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression (CGI) scale, Children and Adolescents' Quality of Life Scale for Gilles de la Tourette Syndrome (C\&A-GTS-QOL) and Child Behavior Checklist (CBCL).
The study will be conducted across five clinical centers: the Children's Hospital of Fudan University, Xiamen Children's Hospital, First People's Hospital of Zunyi, The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine and Dehong Prefecture People's Hospital.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: