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

Last updated: April 12, 2024
Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tinnitus

Treatment

acupuncture

Clinical Study ID

NCT06364670
ZSLL-KY-2023-011-01
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 writteninformed consent.
  • Not participating in other clinical trials concurrently.

Exclusion

Exclusion Criteria:

  • Participants with objective tinnitus.
  • Participants have nervous system diseases or neuropsychiatric diseases that cansignificantly affect brain blood oxygen metabolism assessed by fNIRS.
  • Participants with severe cardiovascular and cerebrovascular diseases, malignant liverand 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 thelast four weeks.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: acupuncture
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • the Third Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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