Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles Versus Flexor Muscles Alone for the Treatment of Essential Hand Tremor (FLEX-D ET)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups.
研究概览
简要总结
To compare the efficacy of botulinum toxin (BoNT) injections in forearm flexors plus extensor muscles versus flexors alone for the treatment of essential hand tremor (ET).
详细描述
The investigators propose a pilot, single center, double blind, randomized, parallel, placebo controlled trial comparing 2 (BoNT) injection patterns for treatment of moderate to severe essential tremor. The investigators will recruit 20 patients with (ET).
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, Investigator)
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
- •Age 18 and over, male or female patient with (ET) involving at least their dominant hand, as diagnosed by a movement disorders neurologist.
- •Having bothersome hand tremor in dominant hand with a hand TRS ≥2
- •On stable medications during last 30 days prior to enrollment.
排除标准
- •Presence of secondary causes of tremor, such as dystonia and parkinsonism
- •Any contraindication to botulinum toxin injections (e.g. motor neuron disease, neuromuscular junction disease, etc.)
- •History of surgical treatment for (ET).
- •Dementia as defined by DSM-V criteria
- •Patients with suboptimally treated depression and significant depressive symptoms as defined by a PHQ-9 score of ≥15 (PHQ-9 scores 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression). Antidepressant medications, prescribed for depression or anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
- •Patients with suboptimally treated anxiety and significant anxiety symptoms as defined by a GAD-7 score of ≥15 (GAD-7 scores 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety). Anti-anxiety medications, prescribed for anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
- •Significant renal, hepatic, cardiac and thyroid disease
研究组 & 干预措施
150 units of abobotulinumtoxinA
150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU)
干预措施: Botulinum toxin (Drug)
150 units of abobotulinumtoxinA
150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU)
干预措施: Placebo (Other)
75 units of abobotulinumtoxinA
75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU
干预措施: Botulinum toxin (Drug)
结局指标
主要结局
Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups.
时间窗: 6 weeks
6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by the patient on a -4 to +4 scale * -4 = severe worsening * 0 = no change * +4 = complete abolishment of symptoms Higher scores represent better outcome.
次要结局
- 12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group.(12 weeks)
- Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups.(Baseline and 6 weeks)
- Difference of the Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 6 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group.(Baseline and 6 weeks)
- Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks.(6 weeks)
- Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups.(6 weeks)
- 12 Week Post Injection in Clinician Global Impression Scale-Improvement Subscale (CGIS)(12 weeks)
- Difference of Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 12 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group.(Baseline and 12 weeks.)
- 12 Week Post Injection Patient Global Impression Scale-Improvement Subscale (PGIS)(12 weeks)