About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
acupuncture
Procedure/SurgeryAcupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36 (Zusanli ), KI3 (Taixi), and etc.
Treatment groups
Trial outcomes
Primary outcomes
Change in resting-state functional connectivity (RSFC)
RSFC will be measured by functional near-infrared spectroscopy (fNIRS).
Change in hemoglobin signals
Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).
Change in Tinnitus Severity Grading
Tinnitus Severity Grading is based on relevant expert consensus.
Secondary outcomes
Change in Tinnitus Handicap Inventory score
Tinnitus Handicap Inventory contains 25 items, each valued at 0-4 points. A larger score indicates a more severe degree of tinnitus.
Change in average pure-tone threshold
The average pure-tone threshold will be assessed by pure-tone audiometry.
Sponsors and contacts
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