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临床试验/NCT02427646
NCT02427646Unknown2 期

Use of Kinematic Assessment of Hand Tremor Pre- and Post- Treatment With Botulinum Toxin Type A in Essential Tremor and Parkinson Disease

Western University, Canada0 个研究点目标入组 54 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
54
主要终点
Clinical Tremor Rating Scale (Fahn-Tolosa-Marin Tremor Rating Scale)

研究概览

简要总结

The present study attempts to fill a critical knowledge gap of BoNT A in tremor management by studying the efficacy of IncobotulinumtoxinA (Xeomin®) injection for hand tremor in essential tremor and idiopathic Parkinson disease using data regarding composition of tremor obtained through sophisticated, yet clinically accessible multi-sensor based kinematic information.

详细描述

Current pharmacological agents used to treat Parkinson disease (PD) tremor and essential tremor (ET) provide suboptimal benefit and are commonly associated with significant adverse effects. Botulinum toxin type A (BoNT-A) has been shown to be effective for wrist tremor though functionally bothersome muscle weakness frequently occurs. This is the longest study to date demonstrating that BoNT-A therapy coupled with kinematic guidance can provide efficacious outcomes for upper limb tremor with minimized unwanted weakness. A total of 28 PD and 24 ET participants with bothersome, disabling tremor, received six serial BoNT-A treatments every 16 weeks starting at week 0 with a follow-up visit 6 weeks following a treatment, totaling 96 weeks. Clinical scales, including Fahn-Tolosa-Marin tremor rating scale (FTM), and sensor-based tremor assessments were conducted at each visit. Kinematics was utilized to identify which arm muscles contributed to the tremulous movements and the experienced injector used clinical expertise in determining BoNT-A dosages. Following BoNT-A treatment, clinical ratings of tremor severity and functional ability (FTM) showed significant improvements following the first treatment which was maintained up to week 96 in PD and ET. Kinematics detected a significant reduction in PD and ET tremor amplitudes by 70% and 76% over the treatment course, respectively. By objectively distinguishing tremulous muscles and tremor severity, adverse effects were limited to mild perceived weakness by participants in injected muscles during follow-ups. Following the fourth treatment, BoNT-A dosages in flexor and extensor wrist muscles and biceps were reduced for those experiencing residual weakness which ultimately did not interfere with tremor relief or arm function. Kinematics is an objective method that can aid clinicians in assessing and determining optimal BoNT-A parameters to alleviate both PD and ET tremor. BoNT-A injections are tolerable and effective when focal therapy regimens are determined and optimized kinematically over a long-term

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

入选标准

  • Consenting male and female participants, aged 18 years to 80 years
  • PD individuals diagnosed by UK Brain Bank Criteria with stage H&Y2-3 disease or ET with hand tremor in their motor dominant hand
  • Stable IPD/ET medication management for the 6 month duration prior to their enrollment in the study
  • Individuals with IPD will be eligible for the study only if tremor is their primary and most bothersome symptom as determined by clinical exam and patient report
  • Participants who are botulinum toxin naïve for tremor management

排除标准

  • History of stroke
  • Muscle weakness or any related compartmental muscle syndrome
  • Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol))
  • Contradictions per the Xeomin® drug monograph
  • Patients prescribed zonisamide

研究组 & 干预措施

ET BoNT-A treatment

Experimental

ET participants treated with kinematic-guided BoNT-A injections over 6 injection cycles

干预措施: BoNT-A (Drug)

PD tremor BoNT-A treatment

Experimental

PD participants treated with kinematic-guided BoNT-A injections over 6 injection cycles

干预措施: BoNT-A (Drug)

结局指标

主要结局

Clinical Tremor Rating Scale (Fahn-Tolosa-Marin Tremor Rating Scale)

时间窗: 0 to 96 weeks

Improvement in hand tremor as determined by a reduction of \>8 points on a standardized clinical assessment tool (Fahn-Tolosa-Marin Tremor Assessment Scale) pre and post Xeomin® injection using kinematic guided injection parameters for both IPD and ET. Lower scores indicate a better outcome. Means and standard deviations are provided in the data tables. FTM minimum and maximum scores range from 0 to 92 FTM points.

次要结局

  • Kinematic Tremor Severity(96 weeks)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mandar Jog

Neurologist, Director of the London Movement Disorders Centre

Western University, Canada

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