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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство frequency-specific rTMS
  Patterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals
• Устройство 1 Hz rTMS
  Low-frequency rTMS will be performed at a frequency of 1Hz

Первичные конечные точки

• Tinnitus Handicap Inventory (THI) [Срок оценки: 5 days from baseline]
• Tinnitus Handicap Inventory (THI) [Срок оценки: 12 days from baseline]
• Tinnitus Handicap Inventory (THI) [Срок оценки: 30 days from baseline]

Вторичные конечные точки (12)

• Visual Analogue Scale (VAS) [Срок оценки: 5 days from baseline]
• Visual Analogue Scale (VAS) [Срок оценки: 12 days from baseline]
• Visual Analogue Scale (VAS) [Срок оценки: 30 days from baseline]
• Minimum Masking Level (MML) [Срок оценки: 5 days from baseline]
• Minimum Masking Level (MML) [Срок оценки: 12 days from baseline]
• Minimum Masking Level (MML) [Срок оценки: 30 days from baseline]
• Tinnitus Loudness Matching (LM) [Срок оценки: 5 days from baseline]
• Tinnitus Loudness Matching (LM) [Срок оценки: 12 days from baseline]
• Tinnitus Loudness Matching (LM) [Срок оценки: 30 days from baseline]
• Duration and intensity of residual inhibition (RI) for tinnitus [Срок оценки: 5 days from baseline]
• Duration and intensity of residual inhibition (RI) for tinnitus [Срок оценки: 12 days from baseline]
• Duration and intensity of residual inhibition (RI) for tinnitus [Срок оценки: 30 days from baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Eye & ENT Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT06635967 · 2024098

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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