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

ConditionTinnitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe Third Affiliated hospital of Zhejiang Chinese Medical University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • acupuncture

    Procedure/Surgery

    Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36 (Zusanli ), KI3 (Taixi), and etc.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: The acupuncture groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in resting-state functional connectivity (RSFC)

RSFC will be measured by functional near-infrared spectroscopy (fNIRS).

Time frame
at baseline (pre-treatment), after 4-week treatment
2

Change in hemoglobin signals

Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).

Time frame
at baseline (pre-treatment), after 4-week treatment
3

Change in Tinnitus Severity Grading

Tinnitus Severity Grading is based on relevant expert consensus.

Time frame
at baseline (pre-treatment), after 4-week treatment

Secondary outcomes

1

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.

Time frame
at baseline (pre-treatment), after 4-week treatment
2

Change in average pure-tone threshold

The average pure-tone threshold will be assessed by pure-tone audiometry.

Time frame
at baseline (pre-treatment), after 4-week treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.