Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention

Tourette syndrome is a refractory type of tic disorder. Previous clinical studies have confirmed that Tuina has a good effect on TS, but the mechanism of action is still uncertain. Studies have found that the pathogenesis of TS may be related to immune factors, and patients will accompanied by the overflow of inflammatory factors such as interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) during the onset of the disease. Other studies have found that the serum levels of IgG1, IgG2, IgG3, IgG4, IgGM, IgGA, IgGE, complement C3 and complement C4 are closely related to the pathogenesis of TS, and the abnormal humoral immune response mediated by food intolerance has an important impact on the pathogenesis of mental illness in children. The immune system plays a very complex role in TS. Based on this, we hypothesized that there may be differences in serum humoral immune effector levels between children with TS and healthy children, whether these differences are related to the consumption of certain allergenic foods or not, and so does Tuina spinal balancing can improve the clinical symptoms of children with TS by changing the levels of inflammatory and immune factors in peripheral serum. This study studied the peripheral mechanism of humoral immune effector mediated by Tourette syndrome and the intervention effect of Tuina through comprehensive scale analysis and advanced laboratory technology, which will provide a scientific theoretical basis and a safe and effective method for the treatment of multiple tics, and will have broad application prospects.

Study Overview

Detailed Description

  1. Evaluation of TS clinical efficacy According to the Yale Tourette's Syndrome Global Severity Scale (YGTSS), the change in clinical control and the improvement rate of YGTSS score and TCM pattern score were evaluated. To investigate the changes in the clinical symptoms of children with TS before and after the intervention of Tuina Spinal Balance Method, and to confirm the effectiveness of this technique.
  2. Serum interleukin-1β (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) detection The levels of cytokines IL-1β, IL-6 and TNF-α in serum were detected by double-antibody sandwich enzyme-linked immunosorbent immunosorbent assay (ABS-ELSIA). To analyze the effect of Tuina spinal balancing method on inflammatory response in children with TS.
  3. Quantitative immunoglobulin assays (1) Serum immunoglobulin IgG, IgM, IgA, IgE and IgG subclasses (IgG-1, IgG-2, IgG-3 and IgG-4) and complement C3 and complement C4 were detected by scattering turbidimetry. To analyze the response of Tuina spinal balancing method to humoral immunity in children with TS.

(2) The food-specific IgG4 and IgE detection kit provided by Beijing Deshankang Technology Co., Ltd. was used to test the serum IgG4 and IgE concentrations of the children by enzyme-linked immunoassay. After food-specific IgG4 and IgE analysis, the distribution of the positive rate of common food intolerance in children with TS was statistically analyzed.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • First Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:
          • xiao Li, Doc.
          • Phone Number: 0571-87072953

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Outpatients who meet the diagnostic criteria for TS;
  • Haven't taken any drugs that affect the efficacy evaluation, such as antipsychotic drugs or traditional Chinese medicines with similar effects, or have received treatment but have passed the drug washout period for more than 1 month before enrollment;
  • The legal guardian and the subject themselves have been informed consent, and have signed the informed consent form, agreeing to participate in this trial, and have been reviewed and approved by the Ethics Committee of Zhejiang Provincial Hospital of Traditional Chinese Medicine.

Exclusion Criteria:

  • Any chorenia, Wilson's disease, epileptic myoclonus, drug-induced extrapyramidal symptoms and other extrapyramidal diseases;
  • A history of severe tics;
  • Any primary diseases such as cardiovascular, hepatic, renal and hematopoietic systems;
  • Allergic or allergic to the drug in this test;
  • Current taking other drugs or accept other treatments at the same time affect the evaluation of efficacy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spinal manipulation

Tuina method:(1) Cervical traction treatment (2) Relaxation techniques: Massage the neck for about 10 minutes with methods such as kneading, etc.

(3) Orthopedic manipulation; (4) Cervicothoracic dorsal extension and wrenching method; (5) Lumbar spine oblique wrenching method;

First Cervical traction,than spine release method,Massage the neck for about 10 minutes to realease muscles.Doctor use his two hands work together to pull the neck forward and upward,meanwhile, the patient's head is passively rotated to the right to the maximum, being rotated slightly with appropriate force, Doctor's left thumb pushes the crooked spinous process to the right, and the reduction sound can be heard at this time.

If patient has upper thoracic spine misalignment, the dislocated segment needs to be adjusted.

If patient has scoliosis, the affected spine segment should also be adjusted. If patient's lumbar facet joints are misaligned, or one of the lumbar muscles is spasmal, also the disorder joints need to be adjusted.

Active Comparator: Relaxation manipulation and medicine
Take Typride tablets (Jiangsu Enhua Pharmaceutical Co., Ltd., Guoyao Zhunzi H32025477). Methods: Oral administration half an hour after meals. Dosage: 50mg/time for 4-7 years old, 75mg/time for 7-12 years old, 100mg/time for 10-18 years old, 2 times/d) for 23 cases each, 2 consecutive weeks for 1 course of treatment.

First Cervical traction,than spine release method,Massage the neck for about 10 minutes to realease muscles.Doctor use his two hands work together to pull the neck forward and upward,meanwhile, the patient's head is passively rotated to the right to the maximum, being rotated slightly with appropriate force, Doctor's left thumb pushes the crooked spinous process to the right, and the reduction sound can be heard at this time.

If patient has upper thoracic spine misalignment, the dislocated segment needs to be adjusted.

If patient has scoliosis, the affected spine segment should also be adjusted. If patient's lumbar facet joints are misaligned, or one of the lumbar muscles is spasmal, also the disorder joints need to be adjusted.

No Intervention: Healthy controls
healthy people

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in scores on Yale global Tic severity scale(YGTSS) at Week4 and Week8
Time Frame: Baseline and Week4 and Week8
These include motor tics, vocal tics, and social impairment scores. Among them, motor and vocal tics were divided into five items: type of tic, frequency, intensity, complexity and interference, each item was recorded as 0, 1, 2, 3, 4 and 5 points. According to the severity, the higher score is , the more severe the severity represent. In order of severity, they are scored as 0 (no effect), 10 (little difficulty), 20 (minor difficulty), 30 (significant difficulty), 40 (fairly difficult) and 50 (very difficult).The sum of motor tics score + vocal tic score + social impairment score is recorded as the total Yale score.
Baseline and Week4 and Week8
Change from Baseline in scores on TCM Syndrome Points at Week4 and Week8
Time Frame: Baseline and Week4 and Week8

The scale includes 5 main symptoms, including frowning or blinking, opening or grinning, shaking or shrugging shoulders, shaking hands or kicking, speaking in different or obscene words, muscle twitches, yellow face or emaciation or obesity, mental fatigue or loss of appetite, difficulty concentrating or forgetfulness and insomnia, irritable temperament or temper or difficulty sitting still or restlessness at night, irregular bowel movements, tongue and pulse.

The main symptoms are scored 0, 1, 2, 3 and 4 points according to the symptoms from mild to moderate, and the secondary symptoms are scored 0, 1 and 2 points respectively according to the symptoms from mild to severe. Tongue quality (pale red 0 points, red 1 point, red 2 points). Tongue coating (0 points for moss peeling, 1 point for moss thin white, 2 points for moss white and greasy), pulse (0 points for peace, 2 points for fine/fine strings).

Baseline and Week4 and Week8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in difference in the spacing of the lantoine side
Time Frame: Baseline and Week4 and Week8
According to X-ray mouth opening images of the child before and after treatment between two groups
Baseline and Week4 and Week8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: xiaojuan Li, The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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