The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus

The aim of this study is to compare the efficacy of frequency-specific patterned repetitive transcranial magnetic stimulation (rTMS) and 1Hz rTMS for the treatment of chronic subjective tinnitus. In this single-blind randomized controlled study, patients will be randomly assigned 1:1 to receive two different types of rTMS stimulation.

Study Overview

• Status: Recruiting
• Conditions: Tinnitus
• Intervention / Treatment: Device: frequency-specific rTMS; Device: 1 Hz rTMS

Detailed Description

Tinnitus is a common disorder with a prevalence of 10-25% among adults, which seriously affects the quality of life of patients. Many studies have reported significant efficacy of repetitive transcranial magnetic stimulation (rTMS) for tinnitus, but its optimal stimulation parameters are not clear. Therefore, there is necessary to assess the clinical efficacy and mechanism of different types of rTMS for the treatment of chronic subjective tinnitus through rigorously designed clinical studies.

The study will assess the severity of tinnitus and the mood and sleep status of the patients through several scales and tinnitus psychoacoustic assessment before treatment, after treatment and at follow-up. The primary research hypothesis is that frequency-specific patterned rTMS will be superior to 1Hz rTMS in reducing tinnitus-related distress.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shan Sun, PhD; Phone Number: +86-021-64377134-2033; Email: sunshine7896@126.com
• Study Contact Backup: Name: Dongmei Tang, PhD; Phone Number: +86-13023299189; Email: tang.dongm@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Eye & ENT Hospital of Fudan University
      • Contact: Shan Sun, PhD; Phone Number: +86-021-64377134-2033; Email: sunshine7896@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged between 18 and 80 years old.
2. Experiencing persistant subjective tinnitus for at least 3 months.
3. A score of 38 or more on THI.
4. 50 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
5. Voluntarily participate in the study and sign the informed consent form.
6. Have normal mental status and cognitive function, and be able to cooperate with the research process.

Exclusion Criteria:

1. Diagnosis of Meniere's disease, conductive hearing loss or objective tinnitus.
2. History of epilepsy or stroke.
3. Diagnosis of acoustic neuroma.
4. Severe sensorineural hearing loss.
5. Surgically or traumatically implanted ferromagnetic foreign bodies, including but not limited to pacemakers, neurostimulators, prosthetic metal heart valves, aneurysm clips (non-titanium alloy), intraocular metal foreign bodies, cochlear implants, metal prostheses, metal joints, fixed steel plates or steel pins.
6. Patients with active metal foreign bodies (metal implants, dentures, contraceptive rings), insulin pumps, etc., who have been evaluated in detail and are at risk for rTMS treatment.
7. Patients taking vestibular sedatives, antipsychotics, anxiolytics, antiepileptics, and ototoxic drugs.
8. Patients with a recent history of alcohol or drug abuse
9. Bell's palsy
10. Acute ear infection within the last 1 month
11. Inability to cooperate or complete the study process
12. Participation in another clinical trial within the last month.
13. Have any condition that may affect compliance or safety
14. Any other condition that, in the opinion of the investigator, makes enrollment in the study inappropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: frequency-specific patterned rTMS; Patients will receive a 5-day, once-daily frequency-specific patterned rTMS treatment via a circular coil applied to the auditory cortex. Each session will last 40 minutes and will be stimulated at an intensity of 80% resting motor threshold (RMT).	Device: frequency-specific rTMS; Patterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals
Active Comparator: 1 Hz rTMS; Patients will receive a 5-day, once-daily 1Hz rTMS treatment via a circular coil applied to the auditory cortex. Each session will last 40 minutes and will be stimulated at an intensity of 80% resting motor threshold (RMT).	Device: 1 Hz rTMS; Low-frequency rTMS will be performed at a frequency of 1Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus Handicap Inventory (THI)	The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).	5 days from baseline
Tinnitus Handicap Inventory (THI)	The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).	12 days from baseline
Tinnitus Handicap Inventory (THI)	The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).	30 days from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder).	5 days from baseline
Visual Analogue Scale (VAS)	Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder).	12 days from baseline
Visual Analogue Scale (VAS)	Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder).	30 days from baseline
Minimum Masking Level (MML)	The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.	5 days from baseline
Minimum Masking Level (MML)	The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.	12 days from baseline
Minimum Masking Level (MML)	The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.	30 days from baseline
Tinnitus Loudness Matching (LM)	Used to measure tinnitus loudness. The level of intensity of an external sound that the patient perceives as equivalent to their tinnitus is used as the LM measurement.	5 days from baseline
Tinnitus Loudness Matching (LM)	Used to measure tinnitus loudness. The level of intensity of an external sound that the patient perceives as equivalent to their tinnitus is used as the LM measurement.	12 days from baseline
Tinnitus Loudness Matching (LM)	Used to measure tinnitus loudness. The level of intensity of an external sound that the patient perceives as equivalent to their tinnitus is used as the LM measurement.	30 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus	Used to measure the duration and intensity of RI for tinnitus.	5 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus	Used to measure the duration and intensity of RI for tinnitus.	12 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus	Used to measure the duration and intensity of RI for tinnitus.	30 days from baseline
Self-rating Anxiety Scale (SAS)	The SAS is a concise, validated tool for assessing anxiety levels in research and clinical settings. It comprises 20 items rated on a 4-point scale, summing to a total score indicating anxiety severity.	5 days from baseline
Self-rating Anxiety Scale (SAS)	The SAS is a concise, validated tool for assessing anxiety levels in research and clinical settings. It comprises 20 items rated on a 4-point scale, summing to a total score indicating anxiety severity.	12 days from baseline
Self-rating Anxiety Scale (SAS)	The SAS is a concise, validated tool for assessing anxiety levels in research and clinical settings. It comprises 20 items rated on a 4-point scale, summing to a total score indicating anxiety severity.	30 days from baseline
Athens Insomnia Scale (AIS)	The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).	5 days from baseline
Athens Insomnia Scale (AIS)	The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).	12 days from baseline
Athens Insomnia Scale (AIS)	The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).	30 days from baseline

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Principal Investigator: Huawei Li, PhD, Eye and ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: repetitive transcranial magnetic stimulation; tinnitus
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 2024098

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No