Tourette Syndrome in ChildrenNCT06379373
Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention
A study testing Spine manipulation; westren medicine in people with Tourette Syndrome in Children and Food Intolerance, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome in Children, Food Intolerance, Inflammatory Response
- What is being tested?
- Spine manipulation; westren medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
xiao Li, Doc., 0571-87072953
About this study
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.
Read the detailed description
- 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.
- 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.
- 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.
- Being tested
- Spine manipulation; westren medicine
- Keywords
- Tuina, Tourette Syndrome, Immune effectors, Mechanism
- Medical subject headings
- Food Intolerance, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine manipulation; westren medicineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: 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. Receives: Other: Spine manipulation; westren medicine |
| Healthy controls | No intervention | healthy people |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline and Week4 and Week8
Secondary outcomes (1)
Change from Baseline in difference in the spacing of the lantoine side
According to X-ray mouth opening images of the child before and after treatment between two groups
Measured: Baseline and Week4 and Week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette Syndrome in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiaojuan Li, Principal investigator, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379373
- Sponsor's protocol ID
- 2023-KLS-190-02
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention
- ClinicalTrials.gov ID
- NCT06379373
- Acronym / sponsor ID
- 2023-KLS-190-02
- Keywords
- Tuina, Tourette Syndrome, Immune effectors, Mechanism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spinal manipulation | Experimental | Other: Spine manipulation; westren medicineTuina 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; |
| Relaxation manipulation and medicine | Active comparator | Other: Spine manipulation; westren medicineTake 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. |
| Healthy controls | No intervention | –healthy people |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spine manipulation; westren medicineFirst 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. | Other | Relaxation manipulation and medicine, Spinal manipulation |
Primary outcome
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.
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).
1 secondary outcome
Change from Baseline in difference in the spacing of the lantoine side
Time frame: Baseline and Week4 and Week8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiaojuan Li principal investigator
The First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spine manipulation; westren medicine in people with Tourette Syndrome in Children and Food Intolerance, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cun wen (+86-571-13857135576, wencunyatb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in scores on Yale global Tic severity scale(YGTSS) at Week4 and Week8 (time frame: Baseline and Week4 and Week8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.