Botulinum Toxin Type A for Injection of Bilateral Upper Extremity Tremor in Patients With Essential Tremor Using Kinematic Assessment
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Kinematic tremor severity
研究概览
简要总结
The primary objective is to study the efficacy of botulinum toxin type A (Xeomin®) injected utilizing kinematically-based injection parameters for the treatment of upper extremity essential tremor (ET). Additional objectives are to study the benefit of kinematic assessment tools in determining injection parameters and to study the composition of tremor using kinematics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting male and female participants
- •Diagnosis of 'definite essential tremor' in accordance with the TRIG criteria including: ET individuals diagnosed with upper limb tremor in their motor dominant and non-dominant hands
- •Stable ET medication management for the 3 month duration prior to their enrollment in the study
- •Participants who are botulinum toxin naïve for tremor management
- •Patients will be screened for pregnancy by the physician
排除标准
- •History of stroke
- •Muscle weakness or any related compartmental muscle syndrome
- •History of ALS or Myasthenia Gravis
- •Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol)
- •Persons prescribed zonisamide
- •History of allergic or side effect reaction to botulinum toxin
- •Contraindications per the Xeomin® drug monograph
- •Women reporting that they are pregnant
研究组 & 干预措施
Essential tremor treatment
A serotype of botulinum toxin type A (BoNT-A) that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction.
Participants will be treated by BoNT-A injections every 12 weeks over 72 weeks. BoNT-A parameters will be determined solely by biomechanical analysis of tremulous movements in both upper extremity BoNT-A dose will range from 50-300 U per arm
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Kinematic tremor severity
时间窗: 72 weeks
Change from pre to post-BoNT-A treatments in maximum angular tremor amplitude at the wrist in each treated arm. Angular tremor amplitude is one parameter reflecting the vectoral intensity of tremor segmented at each arm joint
次要结局
- Clinical tremor severity(72 weeks)
- Accelerometric kinematic tremor severity(72 weeks)
- Quality of life measures(72 weeks)
研究者
Mandar Jog
Principal Investigator
Western University, Canada