Clinical trial NCT06379373: Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention
Official title: Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tourette Syndrome in Children
Food Intolerance
Inflammatory Response
Keywords: Tuina
Tourette Syndrome
Immune effectors
Mechanism
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: According to the order of enrollment, the random number table method was used to divide the massage spinal manipulation+ placebo group (oral placebo, each dose: 50mg/time for 4-7 years old, 75mg/time for 7-12 years old, 100mg/time for 10-18 years old, 2 times/d), relaxation manipulation+ western medicine group (oral Typride tablets, each dose: 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 2 consecutive weeks. Both groups were intervened for 2 courses. The observation time points were 2 weeks, 4 weeks, and 3 months before treatment and after treatment.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in scores on Yale global Tic severity scale(YGTSS) at Week4 and Week8
timeFrame: Baseline and Week4 and Week8
measure: Change from Baseline in scores on TCM Syndrome Points at Week4 and Week8
timeFrame: Baseline and Week4 and Week8
Secondary outcomes:
measure: Change from Baseline in difference in the spacing of the lantoine side
timeFrame: Baseline and Week4 and Week8
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: xiaojuan Li
role: PRINCIPAL_INVESTIGATOR
References: