NCT06379373

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tourette Syndrome in Children
• Food Intolerance
• Inflammatory Response

Interventions

Type	Name	Description
OTHER	Spine manipulation; westren medicine	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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-04-23
• Last updated: 2024-04-23

Locations

1 site across 1 country: China