Идёт набор NCT07267455

Efficacy Analysis of Personalized-Target Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Tinnitus: A Single-Center, Single-Blind Randomized Clinical Trial

Без фазы С лечением Chronic Tinnitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: continuous theta burst stimulation.
Кому может быть актуально: Состояния в реестре: Chronic Tinnitus. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to evaluate the efficacy and safety of personalized-target transcranial magnetic stimulation (TMS) in the treatment of chronic subjective tinnitus. The study aims to determine whether stimulation at individualized auditory cortex targets, identified by resting-state functional MRI, provides greater therapeutic benefit compared with conventional TMS targets. A total of 116 patients with chronic tinnitus will be recruited and randomly assigned to receive either personalized-target TMS or traditional-target TMS for five consecutive days. The main questions this study aims to answer are: Does personalized-target TMS improve tinnitus-related symptoms more effectively than traditional-target TMS? Is personalized-target TMS a safe and tolerable intervention for patients with chronic tinnitus? Researchers will compare the changes in tinnitus-related clinical rating scales between the two groups, including the Tinnitus Handicap Inventory (THI), Visual Analog Scale (VAS), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). Participants will: Receive continuous theta burst stimulation (cTBS) targeting the left auditory cortex region showing the strongest functional connectivity with the parahippocampal gyrus, identified through resting-state fMRI. Undergo three cTBS sessions per day (600 pulses per session, 1,800 pulses total daily) for five days. Complete follow-up assessments at 1 month and 3 months after treatment to evaluate the durability of clinical effects. This study will also assess treatment adherence, safety outcomes, and potential predictors of therapeutic response to personalized-target TMS.

Вмешательства

Устройство continuous theta burst stimulation
This study evaluates personalized-target and conventional-target transcranial magnetic stimulation (TMS) for the treatment of chronic subjective tinnitus. Participants will receive continuous theta burst stimulation (cTBS) applied to the left auditory cortex. For the personalized-target arm, stimulation sites are individualized based on resting-state fMRI, targeting the region of strongest functional connectivity with the parahippocampal gyrus. For the conventional-target arm, stimulation is del

Первичные конечные точки

the effective rate of chronic tinnitus relief in the two groups of patients before treatment and 5 days after treatment [Срок оценки: From enrollment to the end of treatment at 5 days]

Вторичные конечные точки (7)

Tinnitus Loudness [Срок оценки: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up]
Anxiety Symptoms [Срок оценки: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up]
Depressive Symptoms [Срок оценки: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up]
Sleep Quality [Срок оценки: Baseline, post-treatment (day 5), 1-month follow-up, 3-month follow-up]
Long-term Efficacy of Tinnitus Relief [Срок оценки: 1-month follow-up, 3-month follow-up]
EEG Changes [Срок оценки: Baseline (pre-treatment), post-treatment (day 5), 1-month follow-up, 3-month follow-up]
MRI Changes [Срок оценки: Baseline (pre-treatment), 1-month follow-up]

Критерии участия

Критерии включения

1.Patients with tinnitus as the main complaint: Patients perceive subjective sounds in the ears or deep within the skull in the absence of internal or external acoustic stimulation.

2.Patients with chronic tinnitus who meet the conditions including tinnitus duration of more than 6 months, THI (tinnitus handicap inventory) score ≥ 38, and no response to conventional drug treatment.

3.Outpatients of Sun Yat-sen University Sun Yat-sen Memorial Hospital who can receive continuous 5-day cTBS treatment.

4.Tinnitus frequency ranges from 125 Hz to 8000 Hz. 5.Aged 18-70 years.

Критерии исключения

1.Patients with tinnitus associated with the following conditions: conductive hearing loss, a history of middle ear surgery, pulsatile tinnitus caused by vascular malformations, or Meniere's disease.

2.A history of any of the following: head trauma, central nervous system diseases, psychiatric disorders, or substance abuse.

3.Pregnancy.

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

Здоровые добровольцы: Нет