Essential Tremor
Conditions
Keywords
Essential Tremor, Transcranial magnetic stimulation
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.
Interventions
DEVICEreal rTMS
treated with 1HZ rTMS 1800 pulses / day,for 10 days
DEVICEsham rTMS
treated with sham rTMS 1800 pulses / day,for 10 days
Sponsors
Second Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 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. |
| Changes from baseline in tremor analysis | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | This outcome reflects quantitative changes in the patient's tremor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mini-Mental State Examination (MMSE) score from baseline | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 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. |
| Change in Montreal Cognitive Assessment (MOCA) score from baseline | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 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. |
| Changes from baseline in Hamilton Anxiety Scale(HAMA) score | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 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. |
| Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 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. |
| Quality of Life Questionnaire (QUEST) score change from baseline | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 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. |
| Changes from baseline in TMS-EEG | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | Amplitudes of various frequency bands in each cortical region of TMS-EEG reflects change in the patient's brain network. |
| Change in Fatigue Severity Scale (FSS) score from baseline | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | FSS is widely used in the assessment of fatigue. Indicates a health problem associated with fatigue. The higher the score, the worse the fatigue |
| RBD Screening Questionnaire (RBDSQ) score | visit 1(baseline) | 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. |
| test the characteristics of vestibular evoked myogenic potential (VEMP) | visit 1(baseline) | 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. |
| Test the sleep characteristics by polysomnography (PSG) | visit 1(baseline) | This outcome reflects the patient's sleep characteristics and to analyze specific events. |
| test the gene's type of the notch2nlc | visit 1(baseline) | This outcome reflects the genetic diagnosis characteristics of the patient and is helpful for accurate clinical diagnosis and classification |
| Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 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. |
| Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline | visit 1(baseline), visit 2(Day 10), visit 3(Day 30) | 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. |
Countries
China
Contacts
Primary ContactChun-Feng Liu, MD
Backup ContactXiao-Yu Cheng, MD
Outcome results
None listed