the Effects of Repetitive Transcranial Magnetic Stimulation and Mechanisms in Clinical Function of Essential Tremor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Essential Tremor
- Sponsor
- Second Affiliated Hospital of Soochow University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score
- Status
- Recruiting
- Last Updated
- 2 years ago
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.
Investigators
Chun-Feng Liu
Professor
Second Affiliated Hospital of Soochow University
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.
Outcomes
Primary Outcomes
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)
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
Time Frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
This outcome reflects quantitative changes in the patient's tremor.
Secondary Outcomes
- Changes from baseline in TMS-EEG(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Change in Montreal Cognitive Assessment (MOCA) score from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Change in Mini-Mental State Examination (MMSE) score from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Quality of Life Questionnaire (QUEST) score change from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- RBD Screening Questionnaire (RBDSQ) score(visit 1(baseline))
- Changes from baseline in Hamilton Anxiety Scale(HAMA) score(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- Test the sleep characteristics by polysomnography (PSG)(visit 1(baseline))
- Change in Fatigue Severity Scale (FSS) score from baseline(visit 1(baseline), visit 2(Day 10), visit 3(Day 30))
- test the characteristics of vestibular evoked myogenic potential (VEMP)(visit 1(baseline))
- test the gene's type of the notch2nlc(visit 1(baseline))