Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor

Study Overview
=================
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.

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

Conditions
-----------------
Essential Tremor

Intervention / Treatment
-----------------
* Device: real rTMS
* Device: sham rTMS


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS treatment group<br>treated with real rTMS 1800 pulses / day,for 10 days | Device: real rTMS<br>* treated with 1HZ rTMS 1800 pulses / day,for 10 days<br>|
| Sham Comparator: Sham rTMS treatment group<br>treated with sham rTMS 1800 pulses / day,for 10 days | Device: sham rTMS<br>* treated with sham rTMS 1800 pulses / day,for 10 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score | The TETRAS is widely used tremor evaluation scale.TETRAS has been used for evaluation tremor in patients with essential tremor focuses primarily on the assessment of activities of daily living and tremor.The TETRAS score ranges from 0 to 112. The higher the TETRAS score, the more severe the symptoms. | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 
| Changes from baseline in tremor analysis | This outcome reflects quantitative changes in the patient's tremor. | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in TMS-EEG | Amplitudes of various frequency bands in each cortical region of TMS-EEG reflects change in the patient's brain network. | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 
| Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline | This outcome reflects the efficacy of non-motor symptoms. NMSS is a widely used non-motor symptom rating scale that includes 9 domains, The NMSS score ranges from 0 to 360，with higher scores associated with more severe symptoms. | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 
| Change in Mini-Mental State Examination (MMSE) score from baseline | The MMSE is widely used to assess cognition. The MMSE score ranges from 0 to 30. The higher the MMSE score is, the better the cognitive function is. | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 
| Change in Montreal Cognitive Assessment (MOCA) score from baseline | MoCA is widely used to assess cognitive abilities. MOCA scores range from 0 to 30. The higher the MOCA score, the better the cognitive function. | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 
| Changes from baseline in Hamilton Anxiety Scale(HAMA) score | The Hamilton Anxiety Scale(HAMA) is a widely used interview scale to measure the severity of a patient's anxiety.The HAMA score can range from 0 to 56. The higher the HAMA score is, the worse the symptoms are. | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 
| Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score | The Hamilton Depression Scale-24(HAMD-24) is a test measuring the severity of depressive symptoms in individuals. The HAMA score can range from 0 to 56. The higher the HAMA score is, the worse the symptoms are. | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 
| Quality of Life Questionnaire (QUEST) score change from baseline | This outcome reflects the patient's quality of life. QUEST scores range from 0 to 120. The higher the QUEST score, the more severe the symptoms. | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 
| Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline | PSQI is widely used to measure sleep quality. PSQI scores range from 0 to 21. The higher the PSQI score, The worse the quality of sleep. | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 
| Change in Fatigue Severity Scale (FSS) score from baseline | FSS is widely used in the assessment of fatigue. Indicates a health problem associated with fatigue. The higher the score, the worse the fatigue | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 
| RBD Screening Questionnaire (RBDSQ) score | There are 10 questions in total, including the content of dreams, the relationship between dreams and behavior, injuries and neurological diseases, etc. The total score is 0-13 points, and a score of 5 or above is considered abnormal. | visit 1(baseline) | 
| Test the sleep characteristics by polysomnography (PSG) | This outcome reflects the patient's sleep characteristics and to analyze specific events. | visit 1(baseline) | 
| test the characteristics of vestibular evoked myogenic potential (VEMP) | This is a commonly used clinical test that includes cervical vestibular evoked myogenic potential (cvemp) and ocular vestibular evoked myogenic potential (oVEPM) to assess a patient's brainstem pathways. | visit 1(baseline) | 
| test the gene's type of the notch2nlc | This outcome reflects the genetic diagnosis characteristics of the patient and is helpful for accurate clinical diagnosis and classification | visit 1(baseline) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential Tremor, Transcranial magnetic stimulation