Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379373
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-18
Brief Title:
Peripheral Mechanisms of Humoral Immune Effector-mediated Tourettes Syndrome and the Role of Tuina Intervention
Sponsor:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Organization:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Study Overview
Official Title:
Peripheral Mechanisms of Humoral Immune Effector-mediated Tourettes Syndrome and the Role of Tuina Intervention
Status:
RECRUITING
Status Verified Date:
2024-04
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:
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 Tourettes 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
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 Oversight
Has Oversight DMC:
None
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?:
None