Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor

Официальное название

the Effects of Repetitive Transcranial Magnetic Stimulation and Mechanisms in Clinical Function of Essential Tremor

Обзор

The purpose of this study is to evaluate the efficacy and electrophysiology of repetitive transcranial magnetic stimulation in the treatment of essential tremor.

Подробное описание

This is a randomized controlled study.The purpose is to evaluate the efficacy of repetitive transcranial magnetic stimulation(rTMS) in the treatment of essential tremor,and explore the possible mechanism by detecting the changes of clinical scale and TMS-electroencephalogram(TMS-EEG), so as to seek an effective therapy for essential tremor.

Вмешательства

• Устройство real rTMS
  treated with 1HZ rTMS 1800 pulses / day,for 10 days
• Устройство sham rTMS
  treated with sham rTMS 1800 pulses / day,for 10 days

Первичные конечные точки

• The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
• Changes from baseline in tremor analysis [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]

Вторичные конечные точки (12)

• Changes from baseline in TMS-EEG [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
• Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
• Change in Mini-Mental State Examination (MMSE) score from baseline [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
• Change in Montreal Cognitive Assessment (MOCA) score from baseline [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
• Changes from baseline in Hamilton Anxiety Scale(HAMA) score [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
• Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
• Quality of Life Questionnaire (QUEST) score change from baseline [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
• Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
• Change in Fatigue Severity Scale (FSS) score from baseline [Срок оценки: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
• RBD Screening Questionnaire (RBDSQ) score [Срок оценки: visit 1(baseline)]
• Test the sleep characteristics by polysomnography (PSG) [Срок оценки: visit 1(baseline)]
• test the characteristics of vestibular evoked myogenic potential (VEMP) [Срок оценки: visit 1(baseline)]

Критерии участия

Критерии включения

• Diagnosed as essential tremor conforming to the diagnostic criteria for essential tremor in the tremor group of the International Parkinson's and Movement Disorders Society (IPMDS).
• Signed informed consent form.

Критерии исключения

• Complicated with brain organic diseases, epilepsy, other mental diseases, family history of dementia, metal devices implanted in the body and any contraindications to TMS;
• History of craniocerebral surgery;
• TMS cannot cooperate;
• TMS-EEG examination artifacts are obvious, or cannot be analyzed due to other technical reasons.

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

• The Second Affiliated Hospital of Soochow University — Сучжоу

Публикации

• Gironell A, Kulisevsky J, Lorenzo J, Barbanoj M, Pascual-Sedano B, Otermin P. Transcranial magnetic stimulation of the cerebellum in essential tremor: a controlled study. Arch Neurol. 2002 Mar;59(3):413-7. doi: 10.1001/archneur.59.3.413. PMID 11890845
• Lv Y, Wang M, Yang J, Shi J, Xuan T, Zhang J, Du D, Cheng J, Li H. Cerebellar repetitive transcranial magnetic stimulation versus propranolol for essential tremor. Brain Behav. 2023 Mar;13(3):e2926. doi: 10.1002/brb3.2926. Epub 2023 Feb 17. PMID 36806734
• Louis ED, Ferreira JJ. How common is the most common adult movement disorder? Update on the worldwide prevalence of essential tremor. Mov Disord. 2010 Apr 15;25(5):534-41. doi: 10.1002/mds.22838. PMID 20175185
• Louis ED. The Roles of Age and Aging in Essential Tremor: An Epidemiological Perspective. Neuroepidemiology. 2019;52(1-2):111-118. doi: 10.1159/000492831. Epub 2019 Jan 9. PMID 30625472
• Bal N, Sengul Y, Behmen MB, Powell A, Louis ED. Vestibular reflexes in essential tremor: abnormalities of ocular and cervical vestibular-evoked myogenic potentials are associated with the cerebellum and brainstem involvement. J Neural Transm (Vienna). 2023 Dec;130(12):1553-1559. doi: 10.1007/s00702-023-02652-3. Epub 2023 May 18. PMID 37199795
• Berkiten G, Tutar B, Atar S, Kumral TL, Salturk Z, Akan O, Sari H, Onaran O, Biltekin Tuna O, Uyar Y. Assessment of the Clinical Use of Vestibular Evoked Myogenic Potentials and the Video Head Impulse Test in the Diagnosis of Early-Stage Parkinson's Disease. Ann Otol Rhinol Laryngol. 2023 Jan;132(1):41-49. doi: 10.1177/00034894211067838. Epub 2022 Feb 3. PMID 35114808
• Bayramoglu B, Emre U, Erdal Y, Demirhan H, Yasak I, Yalin OO. Cervical vestibular-evoked myogenic potentials in patients with essential tremor. J Clin Neurosci. 2021 Sep;91:365-368. doi: 10.1016/j.jocn.2021.07.015. Epub 2021 Jul 30. PMID 34373053
• Jimenez-Jimenez FJ, Alonso-Navarro H, Garcia-Martin E, Agundez JAG. Sleep disorders in essential tremor: systematic review and meta-analysis. Sleep. 2020 Sep 14;43(9):zsaa039. doi: 10.1093/sleep/zsaa039. PMID 32163585

Идентификаторы

NCT: NCT06145932 · JD-LK2023096-IR01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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