Navigated Repetitive TMS for Chronic Tinnitus

Официальное название

Neuronavigated Transcranial Magnetic Stimulation As An Adjunctive Treatment For Chronic Tinnitus

Обзор

This study is testing whether a special type of brain stimulation called neuronavigated TMS can help reduce tinnitus (ringing in the ears). 50 people with tinnitus will each receive 20 treatment sessions - 10 real treatments and 10 sham treatments in random order, with a 2-week break between them. Before starting, participants get an MRI brain scan to guide where the stimulation device is placed. Questionnaires of measuring tinnitus severity will be asked four times throughout the study to determine to check the effect of TMS on treating tinnitus.

Подробное описание

This study aims to investigate the beneficial effects of neuronavigated TMS (nTMS) in alleviating tinnitus symptoms and to establish safety and tolerability of nTMS in patients with tinnitus.

50 eligible subjects will be recruited and be randomized to receive 10 sessions of daily verum nTMS followed by 10 sessions of daily sham nTMS (verum-sham), or sham nTMS followed by verum nTMS (sham-verum). There will be a 2-week break between the two types of nTMS.

MRI will be conducted before the 1st session of nTMS for the TMS navigation system.

Outcome measures include Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), and Tinnitus-Visual Analogue Scale (T-VAS). All assessment will be evaluated 4 times- before the 1st nTMS session, after the 10th nTMS session, before the 11th nTMS and after the 20th nTMS session.

Вмешательства

• Устройство navigated rTMS
  Each session of rTMS (real or sham) consists of 1200 stimulations/day, conducted at once a day for five consecutive days (from Monday to Friday). For sham stimulation, the TMS coil will still centre on the same scalp position, but it was tilted to 90° so that scalp contact and discharging noise were similar, but the magnetic field did not reach cortical neurons at a biologically active level. The localization of the rTMS stimulation site (left Temporal Cortex) will be directed by a neuronaviga

Первичные конечные точки

• Tinnitus Handicap Inventory (THI) [Срок оценки: Week 0]
• Tinnitus Handicap Inventory (THI) [Срок оценки: Week 3]
• Tinnitus Handicap Inventory (THI) [Срок оценки: Week 6]
• Tinnitus Handicap Inventory (THI) [Срок оценки: Week 7]

Вторичные конечные точки (8)

• Tinnitus Functional Index (TFI) [Срок оценки: Week 0]
• Tinnitus Functional Index (TFI) [Срок оценки: Week 3]
• Tinnitus Functional Index (TFI) [Срок оценки: Week 6]
• Tinnitus Functional Index (TFI) [Срок оценки: Week 7]
• Tinnitus-Visual Analogue Scale (T-VAS) [Срок оценки: Week 0]
• Tinnitus-Visual Analogue Scale (T-VAS) [Срок оценки: Week 3]
• Tinnitus-Visual Analogue Scale (T-VAS) [Срок оценки: Week 6]
• Tinnitus-Visual Analogue Scale (T-VAS) [Срок оценки: Week 7]

Критерии участия

Критерии включения

• Age 21-80 years old;
• Subjective tinnitus severity as per Tinnitus-Visual Analogue Scale of 1/10 and above (in any domain: sound, distress, Quality of Life)

Критерии исключения

• Pregnancy;
• Any metal implants inside the body that are contraindications of MRI scan;
• Cardiac pacemakers;
• Epilepsy with recurrent seizures;
• Cognitively impaired patients will be excluded;
• Claustrophobia;
• Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
• Major depression and a history of psychotic disorders;
• Terminal diagnosis with life expectancy <=1 year.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• Alexandra Hospital — Singapore

Идентификаторы

NCT: NCT07435298 · 2024/4506

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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