Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in severity of essential tremors
研究概览
简要总结
The aim of the study is to investigate the Effect of Repetitive Transcranial Magnetic Stimulation on Essential Tremors.
详细描述
Prior to start of rTMS sessions, Clinical evaluation and scaling of tremors using the ET rating scale (Fahn, Tolosa, Marin Tremor Rating Scale) will be employed on the participants in both groups.
rTMS frequency of 1Hz will be delivered to each of the participants in both groups. Each session will be administered once daily for 3 days a week for 4 weeks. 1200 pulses (30 pulses per train with total 40 trains having inter-train delay of 3 seconds) per session will be provided with the coil placed on both cerebellar hemispheres. rTMS frequency of 1Hz was kept constant based on previous studies.
rTMS sessions will be administered by trained professionals who was kept blinded to the research protocols used in the study. After completion of therapeutic programs (after 4 weeks), the participants will be asked to undergo post assessment of Fahn, Tolosa, Marin Tremor Rating Scale at the end of last rTMS session, 1 month, 3 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with Essential tremors or Essential tremors plus based on the movement disorders consensus criteria(appendix 1)
- •Patient should have significant residual tremors despite of using appropriate medical treatment.
- •Age: patient should be above 18 years old.
- •Gender: males and females.
排除标准
- •Patients with history of seizures.
- •Patient receiving tremor active drugs including:
- •Central cholinergic drugs (acetylcholine chloride, muscarinic and nicotinic agonists, anticholinesterases, and aminopropranolols)
- •Central monoaminergic drugs (neuroleptics, phenylethylamines, and indoles)
- •Peripheral adrenergic drugs (lithium carbonate, amphetamine sulfate, adrenocorticosteroids, and thyroid hormone supplements)
- •Anticonvulsants (valproic acid), bronchodilators (theophylline and terbutaline sulfate)
- •Antidepressants (amitriptyline hydrochloride).
- •patients who have metal or electronic device implanted in their body such as :
- •cardiac peace maker
- •Aneurysm clips or coils
- •Stents in the neck or brain
- •Deep brain stimulators
- •Spinal cord stimulators
- •Electrodes to monitor brain activity
- •Metallic implants in ears and eyes
- •Bullet fragments in or near the head
- •Baclofen pumps
- •Other metal devices or object implanted in or near the head
结局指标
主要结局
change in severity of essential tremors
时间窗: 1 day, 1 month, and 3 months following the end of treatment.
Fahn, Tolosa, Marin Tremor Rating Scale
次要结局
未报告次要终点
研究者
Ahmed Fathy Mohammed Mohammed
physician
Al-Azhar University