Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor
- Conditions
- Essential Tremor
- Interventions
- Device: real rTMSDevice: sham rTMS
- Registration Number
- NCT06145932
- Lead Sponsor
- Second Affiliated Hospital of Soochow University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rTMS treatment group real rTMS treated with real rTMS 1800 pulses / day,for 10 days Sham rTMS treatment group sham rTMS treated with sham rTMS 1800 pulses / day,for 10 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Test the sleep characteristics by polysomnography (PSG) visit 1(baseline) This outcome reflects the patient's sleep characteristics and to analyze specific events.
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 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.
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 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.
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.
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.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
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 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
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, China