Study on the Mechanism of Pei Tu Ning Feng Tang in Alleviating Tourette Syndrome Via Functional Near-Infrared Spectroscopy (fNIRS) and the DA-MAPK-BDNF Pathway

Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. The differences in gut microbiota composition, peripheral blood stress hormones, oxidative stress markers, cytokines, neurotransmitters, and hair cortisol concentrations were observed before and after treatment. Combined with the differences in tic-like behavioral indicators, the therapeutic efficacy of Pei Tu Ning Feng Tang was evaluated. Additionally, TS children underwent two fNIRS examinations before and after treatment to quantitatively describe the activation of brain function by Pei Tu Ning Feng Tang and to investigate its neural mechanisms against tics. Scores were assessed before and after treatment using the Yale Global Tic Severity Scale (YGTSS) and the Traditional Chinese Medicine Syndrome Score Sheet for Pediatric Tourette Syndrome (Spleen Deficiency and Liver Hyperactivity Type) to observe the efficacy of the medication.

Study Overview

• Status: Not yet recruiting
• Conditions: Tourette Syndrome in Children
• Intervention / Treatment: Drug: Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dongdong Qin Qin, Doctor; Phone Number: +86 13888304863; Email: qindong108@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:① Meet the diagnostic criteria for Pediatric Tic Disorder (Spleen Deficiency and Liver Hyperactivity Type) in both traditional Chinese and Western medicine; ② Aged between 4 and 15 years; ③ Guardians provide informed consent, sign the informed consent form, and are able to adhere to the treatment; ④ No visual impairments such as color blindness or color weakness, and no cognitive impairment disorders.

Exclusion Criteria:① Failure to meet the diagnostic criteria for Pediatric Tic Disorder (Spleen Deficiency and Liver Hyperactivity Type) in both traditional Chinese and Western medicine; ② Presence of involuntary movements caused by other diseases, such as Huntington's chorea, hepatolenticular degeneration, myoclonus, epilepsy, etc.; ③ Allergy to any component of the trial medication; ④ Accompanied by severe conditions such as cardiac, hepatic, renal insufficiency, or hematological system disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment.; The differences in gut microbiota composition, peripheral blood stress hormones, oxidative stress markers, cytokines, neurotransmitters, and hair cortisol concentrations were observed before and after treatment.

Drug: Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment.; Preparation of Peitu Ningfeng Decoction: Codonopsis pilosula (Dangshen) 10g, Astragalus membranaceus (Huangqi) 10g, stir-fried Atractylodes macrocephala (Baizhu) 5g, Poria cocos (Fuling) 10g, Paeonia lactiflora (Hangshao) 10g, Uncaria rhynchophylla (Gouteng) 10g, honey-fried Glycyrrhiza uralensis (Zhi Gancao) 10g.Soak the above herbs (except Uncaria rhynchophylla) in boiling water for 30 minutes, then decoct for 20 minutes. Add Uncaria rhynchophylla later during the decoction process. Each dose is decocted three times: First decoction: add about 500 mL of water, bring to a boil over high heat, then simmer over low heat for 20 minutes, and filter to collect the decoction. Second decoction: add about 300 mL of water, bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter to collect the decoction. Third decoction: add about 250 mL of water, bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter to collect the decoction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional near-infrared spectroscopy (fNIRS) was used to detect the degree of brain function activation.	Functional near-infrared spectroscopy (fNIRS) was used to obtain real-time changes in oxygenated hemoglobin (Oxy-Hb) and deoxygenated hemoglobin (Deoxy-Hb) in cerebral cortical tissues under specific conditions, indirectly reflecting alterations in cerebral aerobic metabolism during brain activity. Children with Tourette syndrome (TS) underwent two fNIRS examinations before and after treatment to quantitatively describe the degree of brain function activation by Pei Tu Ning Feng Tang and to investigate its neural mechanisms underlying the suppression of tics.Unit: mmol/L	From enrollment to the end of the one-month treatment period
Relative and absolute quantitative analysis of the gut microbiota.	Fecal samples collected from children with TS were analyzed to determine the composition and relative abundance of the gut microbiota. Additionally, representative samples were randomly selected for absolute quantitative analysis of the gut microbiota, reflecting the actual abundance of each microbial taxon and the true differences in samples before and after treatment.In relative quantitative analysis, results are expressed as percentages (%). In absolute quantitative analysis, results are reported as 16S rRNA gene copies per gram of sample (copies/g).	From enrollment to the end of the one-month treatment period
Determination of Short-Chain Fatty Acids in Feces	In this project, fecal samples were collected from children with TS, and the short-chain fatty acids (SCFAs) in these samples were measured before and after treatment.The commonly used unit for determining SCFAs in feces is micromoles per gram of wet stool weight, i.e., μmol/g wet weight.	From enrollment to the end of the one-month treatment period
Analysis of Stress Hormones	Levels of stress hormones in peripheral blood were measured before and after treatment.For example, cortisol is commonly measured in nanomoles per liter (nmol/L).	From enrollment to the end of the one-month treatment period
Analysis of Oxidative Stress Markers	Levels of oxidative stress markers, including superoxide dismutase (SOD), nitric oxide (NO), and malondialdehyde (MDA), in peripheral blood were measured separately before and after treatment.The units are as follows: superoxide dismutase (SOD) activity in U/mL, nitric oxide (NO) metabolites in μmol/L, and malondialdehyde (MDA) in nmol/mL.	From enrollment to the end of the one-month treatment period
Analysis of Cytokines	Levels of IL-1β, IL-6, and TNF-α in peripheral blood were analyzed before and after treatment.Unit: picogram per milliliter (pg/mL)	From enrollment to the end of the one-month treatment period
Concentration of Neurotransmitters	In this project, the concentrations of neurotransmitters including dopamine (DA), glutamate (Glu), and gamma-aminobutyric acid (GABA) in peripheral blood were measured before and after treatment.The units are as follows: dopamine (DA) in pg/mL, glutamate (Glu) in μmol/L, and gamma-aminobutyric acid (GABA) in nmol/L or pg/mL.	From enrollment to the end of the one-month treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete the questionnaire survey	The Yale Global Tic Severity Scale (YGTSS) was administered to children before and after treatment to evaluate the therapeutic efficacy of the medication. Scores range from 0 to 75, with higher scores indicating greater severity.	From enrollment to the end of the one-month treatment period
Complete the questionnaire survey	The Pediatric Tourette Syndrome Traditional Chinese Medicine Syndrome Score Scale (Spleen Deficiency and Liver Hyperactivity Type) was administered to children before and after treatment to evaluate the therapeutic efficacy of the medication. Scores range from 0 to 54, with higher scores indicating greater severity.	From enrollment to the end of the one-month treatment period

Collaborators and Investigators

• Sponsor: Dongdong Qin

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Ethics Review (2025) No. 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No consent for IPD sharing was obtained from participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No