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

NCT06379373 | Recruiting

• 1 other identifier: 2023-KLS-190-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome in Children; Food Intolerance; Inflammatory Response

Keywords

Tuina; Tourette Syndrome; Immune effectors; Mechanism

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in scores on Yale global Tic severity scale(YGTSS) at 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

  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 Outcomes (1)

• Change from Baseline in difference in the spacing of the lantoine side

  Baseline and Week4 and Week8

Study Arms (3)

Spinal manipulation

EXPERIMENTAL

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;

Other: Spine manipulation; westren medicine

Relaxation manipulation and medicine

ACTIVE COMPARATOR

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.

Other: Spine manipulation; westren medicine

Healthy controls

NO INTERVENTION

healthy people

Interventions

Spine manipulation; westren medicine OTHER

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.

Relaxation manipulation and medicine; Spinal manipulation

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Food Intolerance; Tourette Syndrome

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• xiaojuan Li

  The First Affiliated Hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cun wen

CONTACT

+86-571-13857135576; wencunyatb@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)