Kinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A Therapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 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 (BoNT-A) injected via kinematic parameters in the treatment of unilateral/bilateral upper extremity tremor in Parkinson's disease (PD) tremor. Kinematic assessment tools already developed in past clinical studies will be used in determining injection parameters. The objective is to study the composition of PD tremor using kinematic tools which may contribute to the knowledge of tremor complexity and contribute information that would benefit the development of injection parameters to improve efficacy and optimization of BoNT-A in tremor management. By injecting all bothersome tremulous upper limbs in Parkinson's disease patients, the investigators believe a greater improvement in Quality of Life on more daily tasks can be achieved compared to the investigator's earlier study in unilateral injections (REB#101749), which already showed significant improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •PD individuals diagnosed by UK Brain Bank Criteria with stage H&Y2-3 disease
- •PD participants who are naïve to PD medications will be grouped into the "De novo" PD group
- •PD participants stable on a low dose of Levodopa or on their PD medications for at least 3 months prior to their study enrolment will be grouped into the "L-dopa" PD group
- •Participants who are botulinum toxin naïve for tremor management
- •Patients will be screened for pregnancy by the physician
- •Individuals with PD will be eligible for the study only if tremor is their primary and most bothersome symptom as determined by clinical exam and patient report denoting tremor-dominant phenotype
- •Participants must be able to provide informed consent and to complete all study assessment scales and tasks.
排除标准
- •History of stroke
- •History of ALS or Myasthenia Gravis
- •History of COPD or emphysema
- •Underlying arm muscle weakness or any related compartmental muscle syndrome
- •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 BoNT-A drug monograph
- •Women reporting that they are pregnant
研究组 & 干预措施
De-novo PD
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. BoNT-A peripherally applied using optimal parameters by intramuscular injections solely determined by biomechanical analysis of tremulous movements for tremor therapy in both upper extremity every 12 weeks over 42 weeks. BoNT-A dose will range from 50-300 U per arm
干预措施: Botulinum Toxin Type A (Drug)
L-dopa PD
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. BoNT-A peripherally applied using optimal parameters by intramuscular injections solely determined by biomechanical analysis of tremulous movements for tremor therapy in both upper extremity every 12 weeks over 42 weeks. 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: 42 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(42 weeks)
- Accelerometric kinematic tremor severity(42 weeks)
- Quality of life measures(42 weeks)
研究者
Mandar Jog
Principal Investigator
Western University, Canada