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

April 12, 2024 updated by: Hantong Hu, The Third Affiliated hospital of Zhejiang Chinese Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Third Affiliated hospital of Zhejiang Chinese Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hantong Hu, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The acupuncture group
Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in resting-state functional connectivity (RSFC)
Time Frame: at baseline (pre-treatment), after 4-week treatment
RSFC will be measured by functional near-infrared spectroscopy (fNIRS).
at baseline (pre-treatment), after 4-week treatment
Change in hemoglobin signals
Time Frame: at baseline (pre-treatment), after 4-week treatment
Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).
at baseline (pre-treatment), after 4-week treatment
Change in Tinnitus Severity Grading
Time Frame: at baseline (pre-treatment), after 4-week treatment
Tinnitus Severity Grading is based on relevant expert consensus.
at baseline (pre-treatment), after 4-week treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tinnitus Handicap Inventory score
Time Frame: 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.
at baseline (pre-treatment), after 4-week treatment
Change in average pure-tone threshold
Time Frame: at baseline (pre-treatment), after 4-week treatment
The average pure-tone threshold will be assessed by pure-tone audiometry.
at baseline (pre-treatment), after 4-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Investigators

  • Principal Investigator: Hantong Hu, M.D, The Third Affiliated hospital of Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSLL-KY-2023-011-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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