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NCT Number: NCT06635967

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location status: Recruiting

Location contact

Shan Sun, PhD

CONTACT

[email protected]

+86-021-64377134-2033

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diagnosis of Meniere's disease, conductive hearing loss or objective tinnitus.
  • History of epilepsy or stroke.
  • Diagnosis of acoustic neuroma.
  • Severe sensorineural hearing loss.
  • 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.
  • 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.
  • Patients taking vestibular sedatives, antipsychotics, anxiolytics, antiepileptics, and ototoxic drugs.
  • Patients with a recent history of alcohol or drug abuse
  • Bell's palsy
  • Acute ear infection within the last 1 month
  • Inability to cooperate or complete the study process
  • Participation in another clinical trial within the last month.
  • Have any condition that may affect compliance or safety
  • Any other condition that, in the opinion of the investigator, makes enrollment in the study inappropriate.

Treatment and study plan

frequency-specific rTMS

Device

Patterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals

1 Hz rTMS

Device

Low-frequency rTMS will be performed at a frequency of 1Hz

Primary outcomes

  1. Tinnitus Handicap Inventory (THI)

    Time frame: 5 days from baseline

    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).

  2. Tinnitus Handicap Inventory (THI)

    Time frame: 12 days from baseline

    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).

  3. Tinnitus Handicap Inventory (THI)

    Time frame: 30 days from baseline

    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).

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 5 days from baseline

    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).

  2. Visual Analogue Scale (VAS)

    Time frame: 12 days from baseline

    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).

  3. Visual Analogue Scale (VAS)

    Time frame: 30 days from baseline

    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).

  4. Minimum Masking Level (MML)

    Time frame: 5 days from baseline

    The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.

  5. Minimum Masking Level (MML)

    Time frame: 12 days from baseline

    The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.

  6. Minimum Masking Level (MML)

    Time frame: 30 days from baseline

    The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.

  7. Tinnitus Loudness Matching (LM)

    Time frame: 5 days from baseline

    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.

  8. Tinnitus Loudness Matching (LM)

    Time frame: 12 days from baseline

    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.

  9. Tinnitus Loudness Matching (LM)

    Time frame: 30 days from baseline

    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.

  10. Duration and intensity of residual inhibition (RI) for tinnitus

    Time frame: 5 days from baseline

    Used to measure the duration and intensity of RI for tinnitus.

  11. Duration and intensity of residual inhibition (RI) for tinnitus

    Time frame: 12 days from baseline

    Used to measure the duration and intensity of RI for tinnitus.

  12. Duration and intensity of residual inhibition (RI) for tinnitus

    Time frame: 30 days from baseline

    Used to measure the duration and intensity of RI for tinnitus.

  13. Self-rating Anxiety Scale (SAS)

    Time frame: 5 days from baseline

    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.

  14. Self-rating Anxiety Scale (SAS)

    Time frame: 12 days from baseline

    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.

  15. Self-rating Anxiety Scale (SAS)

    Time frame: 30 days from baseline

    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.

  16. Athens Insomnia Scale (AIS)

    Time frame: 5 days from baseline

    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).

  17. Athens Insomnia Scale (AIS)

    Time frame: 12 days from baseline

    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).

  18. Athens Insomnia Scale (AIS)

    Time frame: 30 days from baseline

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dongmei Tang, PhD

CONTACT

[email protected]

+86-13023299189

Shan Sun, PhD

CONTACT

[email protected]

+86-021-64377134-2033

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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