Recruiting NCT06145932
Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: real rTMS, sham rTMS.
- Who it may be relevant to
- Registry conditions: Essential Tremor. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
the Effects of Repetitive Transcranial Magnetic Stimulation and Mechanisms in Clinical Function of Essential Tremor
Overview
The purpose of this study is to evaluate the efficacy and electrophysiology of repetitive transcranial magnetic stimulation in the treatment of essential tremor.
Detailed description
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.
Interventions
- Device real rTMS
treated with 1HZ rTMS 1800 pulses / day,for 10 days - Device sham rTMS
treated with sham rTMS 1800 pulses / day,for 10 days
Primary outcome measures
- The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
- Changes from baseline in tremor analysis [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
Secondary outcome measures (12)
- Changes from baseline in TMS-EEG [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
- Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
- Change in Mini-Mental State Examination (MMSE) score from baseline [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
- Change in Montreal Cognitive Assessment (MOCA) score from baseline [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
- Changes from baseline in Hamilton Anxiety Scale(HAMA) score [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
- Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
- Quality of Life Questionnaire (QUEST) score change from baseline [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
- Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
- Change in Fatigue Severity Scale (FSS) score from baseline [Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)]
- RBD Screening Questionnaire (RBDSQ) score [Time frame: visit 1(baseline)]
- Test the sleep characteristics by polysomnography (PSG) [Time frame: visit 1(baseline)]
- test the characteristics of vestibular evoked myogenic potential (VEMP) [Time frame: visit 1(baseline)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Soochow University — Suzhou
Publications
- 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
Identifiers
NCT: NCT06145932 · JD-LK2023096-IR01