Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: acupuncture.
- Who it may be relevant to
- Registry conditions: Tinnitus. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This trial aims to use machine learning to analyze fNIRS imaging data of specific brain regions of tinnitus patients, thereby constructing a predictive model of the clinical efficacy of acupuncture for SNT.
Detailed description
This study will recruit 500 subjects with tinnitus. Functional near-infrared spectroscopy (fNIRS) will be employed to examine specific brain regions, and the corresponding fNIRS imaging data from all detection channels will be extracted. Subsequently, the subjects will undergo a course of acupuncture treatment. Based on the recovery status of tinnitus at the conclusion of the acupuncture course, all subjects will be categorized into a "good prognosis group" and a "poor prognosis group" according to relevant efficacy criteria. The entire dataset will then be randomly divided into a training set (70%) and a test set (30%) following a 7:3 ratio.
Interventions
- Procedure acupuncture
Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36 (Zusanli ), KI3 (Taixi), and etc.
Primary outcome measures
- Change in resting-state functional connectivity (RSFC) [Time frame: at baseline (pre-treatment), after 4-week treatment]
- Change in hemoglobin signals [Time frame: at baseline (pre-treatment), after 4-week treatment]
- Change in Tinnitus Severity Grading [Time frame: at baseline (pre-treatment), after 4-week treatment]
Secondary outcome measures (2)
- Change in Tinnitus Handicap Inventory score [Time frame: at baseline (pre-treatment), after 4-week treatment]
- Change in average pure-tone threshold [Time frame: at baseline (pre-treatment), after 4-week treatment]
Eligibility criteria
Inclusion criteria
- Bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus.
- Male and female, aged between 18 and 60 years.
- Right-handed subjects who are able to comply with the study protocol and sign written informed consent.
- Not participating in other clinical trials concurrently.
Exclusion criteria
- Participants with objective tinnitus.
- Participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by fNIRS.
- Participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases.
- Participants have any contraindications for acupuncture (such as a bleeding tendency).
- Pregnant or lactating women.
- Participants have received tinnitus treatment with drugs or other therapies in the last four weeks.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- the Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou
Publications
- Huang X, Jiang D, Kong D, Liu H, Chen L, Li Y, Zhou J, Gao H, Hu H. Predicting Individual Response to Acupuncture in Sensorineural Tinnitus Using Integrated Functional Near-Infrared Spectroscopy and Machine Learning: Protocol for a Model Development and Validation Study. J Multidiscip Healthc. 2025 Oct 9;18:6579-6593. doi: 10.2147/JMDH.S550296. eCollection 2025. PMID 41089742
Identifiers
NCT: NCT06364670 · ZSLL-KY-2023-011-01