Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus

Tinnitus Clinical Trial

Official title:

Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06364670
• Other study ID #: ZSLL-KY-2023-011-01
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: Xiaohan Huang, M.M
• Phone: 18334334738
• Email: 1215360683[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.

Locations

Country	Name	City	State
China	the Third Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in resting-state functional connectivity (RSFC)	RSFC will be measured by functional near-infrared spectroscopy (fNIRS).	at baseline (pre-treatment), after 4-week treatment
Primary	Change in hemoglobin signals	Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).	at baseline (pre-treatment), after 4-week treatment
Primary	Change in Tinnitus Severity Grading	Tinnitus Severity Grading is based on relevant expert consensus.	at baseline (pre-treatment), after 4-week treatment
Secondary	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.	at baseline (pre-treatment), after 4-week treatment
Secondary	Change in average pure-tone threshold	The average pure-tone threshold will be assessed by pure-tone audiometry.	at baseline (pre-treatment), after 4-week treatment