Clinical trial NCT06145932: Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor
Official title: the Effects of Repetitive Transcranial Magnetic Stimulation and Mechanisms in Clinical Function of Essential Tremor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Essential Tremor
Keywords: Essential Tremor
Transcranial magnetic stimulation
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Signed informed consent form.

Exclusion Criteria:

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

Primary outcomes:
measure: The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
measure: Changes from baseline in tremor analysis
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary outcomes:
measure: Changes from baseline in TMS-EEG
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
measure: Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
measure: Change in Mini-Mental State Examination (MMSE) score from baseline
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
measure: Change in Montreal Cognitive Assessment (MOCA) score from baseline
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
measure: Changes from baseline in Hamilton Anxiety Scale(HAMA) score
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
measure: Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
measure: Quality of Life Questionnaire (QUEST) score change from baseline
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
measure: Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
measure: Change in Fatigue Severity Scale (FSS) score from baseline
timeFrame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
measure: RBD Screening Questionnaire (RBDSQ) score
timeFrame: visit 1(baseline)
measure: Test the sleep characteristics by polysomnography (PSG)
timeFrame: visit 1(baseline)
measure: test the characteristics of vestibular evoked myogenic potential (VEMP)
timeFrame: visit 1(baseline)
measure: test the gene's type of the notch2nlc
timeFrame: visit 1(baseline)
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Chun-Feng Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bugalho P, Salavisa M, Borbinha C, Fernandes M, Meira B, Barbosa R, Mendonca M. REM sleep behaviour disorder in essential tremor: A polysomnographic study. J Sleep Res. 2021 Apr;30(2):e13050. doi: 10.1111/jsr.13050. Epub 2020 Apr 23.
citation: Rekik A, Nasri A, Mrabet S, Gharbi A, Souissi A, Gargouri A, Kacem I, Gouider R. Non-motor features of essential tremor with midline distribution. Neurol Sci. 2022 Oct;43(10):5917-5925. doi: 10.1007/s10072-022-06262-x. Epub 2022 Jul 18.