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

NCT07417371 | Not Yet Recruiting

• 1 other identifier: Ethics Review (2025) No. 2
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tourette Syndrome in Children

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Complete the questionnaire survey

  From enrollment to the end of the one-month treatment period

• Complete the questionnaire survey

  From enrollment to the end of the one-month treatment period

Study Arms (1)

Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment.

EXPERIMENTAL

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.

Interventions

Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. DRUG

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.

Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment.

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Dongdong Qin: lead

Central Study Contacts

Dongdong Qin Qin, Doctor

CONTACT

+86 13888304863; qindong108@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: 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 Record Dates

• First Submitted: February 2, 2026
• First Posted: February 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share