Tinnitus
Conditions
Keywords
acupuncture, moxibustion, tinnitus, fNIRS, machine learning
Brief summary
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
PROCEDUREacupuncture
Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36 (Zusanli ), KI3 (Taixi), and etc.
Sponsors
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in resting-state functional connectivity (RSFC) | at baseline (pre-treatment), after 4-week treatment | RSFC will be measured by functional near-infrared spectroscopy (fNIRS). |
| Change in hemoglobin signals | at baseline (pre-treatment), after 4-week treatment | Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS). |
| Change in Tinnitus Severity Grading | at baseline (pre-treatment), after 4-week treatment | Tinnitus Severity Grading is based on relevant expert consensus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tinnitus Handicap Inventory score | at baseline (pre-treatment), after 4-week treatment | 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 | at baseline (pre-treatment), after 4-week treatment | The average pure-tone threshold will be assessed by pure-tone audiometry. |
Countries
China
Contacts
Primary ContactXiaohan Huang, M.M
Outcome results
None listed