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Acupuncture for Tic Disorder in Children: Study Protocol for a Randomized Sham-Controlled Trial Integrating Functional Near-Infrared Spectroscopy and Untargeted Metabolomics
ABSTRACT
Background:
Acupuncture is increasingly used in the management of tic disorder (TD) in children, but treatment response is still assessed mainly using symptom-based rating scales, with limited support from objective biological measures. Peripheral metabolic disturbances and cortical function abnormalities may contribute to the pathophysiology of TD.
Objective:
This randomized sham-controlled trial aims to evaluate clinical effects of acupuncture in children with TD and to explore treatment-related changes in peripheral metabolism and prefrontal cortical function using clinical assessments, serum untargeted metabolomics, and functional near-infrared spectroscopy (fNIRS).
Methods:
This single-center, randomized, sham-controlled, parallel-group trial will enroll 70 children aged 6–12 years with TD and randomly assign them 1:1 to acupuncture plus CBIT or nonpenetrating sham acupuncture plus CBIT. Treatment will be administered twice weekly for 8 weeks. The primary outcome is the change in Yale Global Tic Severity Scale score from baseline to week 8. Secondary outcomes include SNAP-IV, SDQ, SAS, SDS, prefrontal functional near-infrared spectroscopy, serum untargeted metabolomics, and safety assessments.
Results:
Participant recruitment is ongoing and is expected to be completed by 28 February 2027. The study is anticipated to provide evidence on the clinical effects of acupuncture and associated changes in prefrontal cortical function and peripheral metabolic profiles in children with TD.
Conclusions:
This trial will evaluate the adjunctive effects of acupuncture in children with TD and explore treatment-related cortical functional and metabolic changes, providing complementary clinical and biological evidence for future research.
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Copyright
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