Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder
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: Repetitive transcranial magnetic stimulation, Sham stimulation.
- Кому может быть актуально
- Состояния в реестре: Somatic Symptom Disorder. Базовые параметры: 20 лет — 70 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
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder: A Randomized Double-blind Sham-controlled Crossover Study
Обзор
This is a randomized double-blind sham-controlled crossover study; the interventions are high-frequency rTMS stimulation on left DLPFC and sham control. The study population is the patient with somatic symptom disorder. The primary outcomes are somatic distress and health anxiety.
Подробное описание
Somatic symptom disorder (SSD) is a psychiatric diagnosis featured with somatic distress and health anxiety. It is overlapped with functional disorders. Whether it has effective treatment is a clinically important issue. Current evidence indicates that pharmacotherapy and psychotherapy are both helpful for SSD. Among other treatment options, repetitive transcranial magnetic stimulation (rTMS) is attached important in psychiatric field; it can cause activation or inhibition of specific brain regions via magnetic stimulation. Previous studies have disclosed that rTMS is helpful for depression, obsessive-compulsive disorder, post-stroke rehabilitation, etc. Regarding functional disorders, fibromyalgia has been found to be benefited from rTMS; the effective approaches include giving high-frequency stimulation on left M1 and dorsolateral prefrontal cortex (DLPFC). Chronic tinnitus was also found to have response to rTMS. SSD and fibromyalgia are highly overlapped; SSD and depression are often comorbid. Therefore, SSD may also be benefited from left DLPFC high-frequency stimulation. Our previous study revealed that dysfunction of anterior cingulate cortex (ACC) is associated with persistent interference of the somatic discomforts; stimulation on DLPFC can cause ACC activation. This study program was designed based on the above information. It is a randomized double-blind sham-controlled crossover study; the interventions are high-frequency rTMS stimulation on left DLPFC and sham control. The primary outcomes are somatic distress and health anxiety. There is not study about rTMS on SSD in literature; the investigators expect this study to be able to provide more understanding on this field.
Вмешательства
- Устройство Repetitive transcranial magnetic stimulation
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses - Устройство Sham stimulation
High-frequency stimulation (10Hz), 120% motor threshold, 40 trains, 1600 pulses (with sham coil)
Первичные конечные точки
- Scores of Patient Health Questionnaire-15 (PHQ-15) [Срок оценки: Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
- Scores of Health Anxiety Questionnaire (HAQ) [Срок оценки: Week 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Вторичные конечные точки (7)
- Scores of Patient Health Questionnaire-15 (PHQ-15) [Срок оценки: Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)]
- Scores of Health Anxiety Questionnaire (HAQ) [Срок оценки: Week 1, 2 (comparing with the data in week 0) of the two sections (rTMS and sham)]
- Scores of Beck Depression Inventory-II (BDI-II) [Срок оценки: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
- Scores of Beck Anxiety Inventory (BAI) [Срок оценки: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
- Scores of Cognitions About Body and Health Questionnaire (CABAH) [Срок оценки: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
- Heart rate variability [Срок оценки: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
- Skin conductance [Срок оценки: Week 1, 2, 3 (comparing with the data in week 0) of the two sections (rTMS and sham)]
Критерии участия
Критерии включения
- Patient with somatic symptom disorder (confirmed by psychiatrists)
- Age 20-70
Критерии исключения
- Having psychotic symptoms or cognitive impairment
- Having potentially lethal illness
- Using cardiac pacemakers or defibrillators
- Currently pregnant or having plans to become pregnant within the next three months
- Received rTMS treatment within three months
- Cannot read the questionnaires by oneself
- Having to take the following medications persistently: bupropion >300 mg/day、TCA、clozapine、chlorpromazine、foscarnet、ganciclovir、ritonavir、theophylline
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
Тайвань · 1 центр
- National Taiwan University Hospital Yunlin Branch — Douliu
Идентификаторы
NCT: NCT05161819 · 202109065DINC